With a new administration comes a fresh wave of changes at the Food and Drug Administration (FDA) and Department of Health and Human Services (HHS), bringing shifts in leadership, policy priorities, and regulatory approaches. These adjustments will impact a wide range of industries, from medical devices and pharmaceuticals to tobacco, cosmetics, and food. This timeline will serve as a living document, tracking key updates, regulatory changes, and agency directives in real time, helping stakeholders stay informed and prepared for what’s ahead.
Check back regularly for the latest developments as the new FDA and HHS takes shape.
September 23, 2025 | FDA Issues Final Guidance on Computer Software Assurance for Production and Quality System Software
FDA has released a final guidance on how it will approach enforcement discretion for in vitro diagnostic tests (IVDs) during Section 564 declared emergencies. The guidance outlines when FDA may allow use of unapproved or off-label tests to expand diagnostic capacity in a crisis, what factors (public health need, benefits vs. risks, alternatives, mitigations) the Agency will weigh, and how such policies will begin and end. This framework gives test developers and labs clearer expectations during emergencies, balancing rapid access with patient safety.
Click here for more information.
September 23, 2025 | FDA Issues Final Guidance on Enforcement Discretion for In Vitro Diagnostic Tests in Declared Emergencies
September 19, 2025 | FDA Officially Rescinds LDT Final Rule
On September 19, 2025, the FDA elected to amend the wording of its LDT Final Rule that would have reclassified laboratory-developed tests (LDTs) as medical devices. Last week, RFK Jr. issued an entry into the Federal Register titled Medical Devices; Laboratory Developed Tests; Implementation of Vacatur, stating that the FDA was removing the words “including when the manufacturer of these products is a laboratory” from the Final Rule, effectively reverting to the text of the regulation as it existed before the Final Rule’s effective date. This move follows a March 31, 2025, decision by the U.S. District Court for the Eastern District of Texas to vacate the 2024 rule in its entirety.
Read the full update here.
September 10, 2025 | HHS and CBP Seize $86.5 Million in Illegal E-Cigarettes in Largest U.S. Operation to Date
In a coordinated operation in Chicago, HHS (through the FDA) and U.S. Customs and Border Protection seized 4.7 million unauthorized e-cigarette products valued at about $86.5 million, constituting the largest seizure of its kind. Many of the shipments were traced to China and found to use misleading descriptions and incorrect values, apparently intended to evade import duties and safety reviews. All seized e-cigarette products lacked the FDA’s required premarket authorization, making them illegal for marketing or sale in the U.S. The agencies also contacted 37 importers, reminding them of their legal responsibilities and providing 30 days to respond with accurate import documentation.
September 10, 2025 | FDA Issues Draft Guidance to Expand Non-Opioid Treatment Options for Chronic Pain
The FDA has released draft guidance titled “Development of Non-Opioid Analgesics for Chronic Pain” aimed at accelerating the development of safe, effective non-opioid pain treatments to help reduce opioid prescriptions and misuse. The guidance addresses trial design, patient selection, measuring meaningful outcomes (including reducing opioid reliance), and use of expedited pathways. It fulfills a requirement under the SUPPORT Act and opens a 60-day public comment period so stakeholders can provide feedback.
September 9, 2025 | FDA Announces Crackdown on Deceptive Drug Advertising
The FDA is increasing enforcement actions against drug advertisements that mislead consumers or omit required safety information, including side effects. It plans to issue about 100 cease-and-desist orders and thousands of warning letters to pharmaceutical firms, online pharmacies, telehealth companies, and social media influencers. The agency is also targeting a regulatory loophole (“adequate provision”) that allows some ads to avoid fully disclosing all risks, in order to ensure greater transparency in direct-to-consumer drug marketing.
September 5, 2025 | FDA Launches “Green List” to Block Illegally Imported GLP-1 Drug Ingredients
The FDA has established a “green list” import alert designed to stop unverified foreign sources of GLP-1 active pharmaceutical ingredients (APIs) from entering the U.S. market. The list will include only those GLP-1 APIs from facilities inspected or evaluated by the FDA that meet U.S. compliance standards; APIs from other sources may be detained without physical examination. The move comes amid concern over compounded versions of drugs like semaglutide and tirzepatide, which in some cases have had dosing errors, use of unapproved salt forms, and adverse events reported. The agency plans to continue working with state regulators, monitoring the market, and enforcing regulations to prevent unsafe or fraudulent GLP-1 drugs from reaching consumers.
September 4, 2025 | FDA to Publish Complete Response Letters in Real Time, Releases Previously Unreleased Batch of 89
The FDA has announced it will begin promptly releasing Complete Response Letters (CRLs) as soon as they are issued to drug sponsors. It has also published a batch of 89 CRLs from 2024 to present that had not been previously disclosed, each outlining safety or effectiveness issues that prevented approval. The published letters are redacted to remove confidential commercial, trade secret, and personal private information, but will include company names, aiming to improve transparency and help drug developers avoid common filing deficiencies.
September 3, 2025 | FDA Introduces New Evidence Framework to Support Rare Disease Drug Development
Today, the FDA has introduced the Rare Disease Evidence Principles (RDEP), a framework designed to expedite and clarify the review of therapies for rare diseases caused by known genetic defects, particularly when patient populations are small and current treatments are inadequate. Under RDEP, sponsors may rely on a combination of one adequate and well-controlled study plus additional evidence, such as biomarkers, non-clinical models, natural history data, case reports, or pharmacodynamic data, to meet the statutory standard of demonstrating effectiveness. To participate, the therapy must target a very small, rare disease population (typically fewer than 1,000 patients in the U.S.), address rapid deterioration with serious consequences, and have no adequate alternative therapies; requests must be made before pivotal trials begin. Drugs approved under this process may also be subject to post-marketing requirements to further verify safety and efficacy.
September 2, 2025 | FDA Urges Nicotine Pouch Manufacturers To Use Child-Resistant Packaging Following Increasing Reports of Accidental Exposure
The FDA is calling on manufacturers of nicotine pouches to adopt child-resistant packaging in response to a rising number of accidental exposure cases, especially among children under five, reported to U.S. Poison Centers between April 2022 and March 2025. The agency also urges parents and caregivers to store nicotine products securely, in their original packaging, and to call Poison Control immediately if ingestion occurs.
August 9, 2025 | Prasad Resumes Role as CBER Director at FDA’s Request
In less than two weeks following his departure from the agency, Dr. Vinay Prasad has returned to resume his role as Director of FDA’s Center for Biologics Evaluation and Research. Prasad had previously stepped down following escalating tensions related to a gene therapy product for Duchenne’s muscular dystrophy and a campaign launched by right-wing influencer Laura Loomer.
A spokesperson for HHS said that “Neither the White House nor HHS will allow the fake news media to distract from the critical work the FDA is carrying out under the Trump administration,” and that “at FDA’s request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,”
August 6, 2025 | RFK Jr. Cancels 22 mRNA Contracts, Totaling Approximately 500 Million USD
HHS Commissioner Robert F Kennedy Jr., announced today on the social media platform “X”, that he has instructed the Biomedical Advanced Research and Development Authority (BARDA) to cancel 22 mRNA vaccine development contracts, totaling approximately $500 million US dollars. RFK Jr. stated the reason for the cancellation of these contracts was “because the data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu.” Kennedy went on to further state that the agency will now be “shifting that funding toward safer, broader vaccine platforms that remain effective even as viruses mutate.” – @SecKennedy, X
August 4, 2025 | Sean Keveney Appointed Chief Counsel at the FDA
The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) today announced that Sean Keveney has been appointed Chief Counsel at the FDA. Keveney most recently served as Acting General Counsel of HHS, where he led the Department’s legal team in advancing key administration priorities and ensuring rigorous legal standards across public health programs.
July 31, 2025 | Sridhar Mantha Named FDA Chief Information Officer
The Agency’s website was updated today to reflect the appointment of Sridhar Mantha to the position of Chief Information Officer at FDA. In this role, Mantha sets and leads the agency’s Information Technology (IT) strategy, as well as the enterprise IT, data management, and cybersecurity strategies within the Office of Digital Transformation.
Mantha most recently served as director of the Office of Strategic Programs (OSP) in the FDA’s Center for Drug Evaluation and Research (CDER), overseeing strategy development, program management, advanced analytics, and informatics for CDER’s regulatory processes. Prior to that role, he served as director of the Office of Business Informatics in OSP, where he led and coordinated informatics activities across CDER. Since May 2025, he has been leading multiple agency-wide initiatives, such as the ELSA GenAI program.
July 30, 2025 | Dr. Vinay Prasad, Director of CBER at FDA, Departs Agency After Less Than 3 Months In Office
In a statement made to the news outlet, STAT, Health and Human Services Department spokesperson Andrew Nixon said, “Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family. We thank him for his service and the many important reforms he was able to achieve in his time at FDA.”
In Prasad’s absence, George Tidmarsh, who was recently appointed to lead the FDA’s Center for Drug Evaluation and Research, will now also be the acting CBER director, according to the agency’s website.
July 25, 2025 | Caleb Michaud Named FDA Acting Associate Commissioner for External Affairs
The Agency’s leadership profiles website has been updated today to reflect the appointment of Caleb Michaud to the position of Acting Associate Commissioner for External Affairs. In this role, he will lead the Agency’s communications and outreach efforts to the news media, health professionals, patient advocates, industry, states, consumer groups, and the general public. According to the profile, prior to this role, Mr. Michaud served as the Director of Organizational Communication and Engagement in the FDA Office of Inspections and Investigations (OII), where he led OII’s strategic communication, web and digital media, public affairs, ombudsman, and executive secretariat work. Before assuming this role, he was the deputy director for the Office of Communication and Project Management.
July 14, 2025 | FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine
The U.S. Food and Drug Administration today announced seven recent warning letters sent to companies for illegally marketing products containing 7-hydroxymitragynine, also known as 7-OH.1 This action reflects the Agency’s growing concern around novel potent opioid products being marketed to U.S. consumers and sold online and in smoke shops, gas stations, and corner stores. While 7-OH occurs naturally in trace amounts in kratom, the Agency’s letters focus on concentrated 7-OH products such as tablets, gummies, drink mixes, and shots, which may be dangerous.
July 14, 2025 | FDA Approves New Natural Blue Food Color Additive, Pushes for Faster Phase-Out of Red Dye No. 3
Today, the U.S. Food and Drug Administration announced it had granted Gardenia Blue Interest Group’s (GBIG) color additive petition to use the color gardenia (genipin) blue in various foods, at levels consistent with good manufacturing practice. It is the fourth color derived from natural sources approved by the FDA for use in foods in the last two months.
In addition to approving a new color additive, the FDA also announced today that it had sent a letter to manufacturers encouraging them to accelerate the phase-out of FD&C Red No. 3 in foods, including dietary supplements, sooner than the January 15, 2027, required deadline. This earlier phase-out was another of the series of measures introduced by Secretary Kennedy in April.
July 14, 2025 | HHS Finalizes Layoffs Following Supreme Court Decision
Staff members who were first notified of terminations in April were officially let go late Monday, following a supreme court decision allowing the federal government to proceed with the mass firings. In addition to the previously notified departures, HHS Secretary Robert F. Kennedy Jr. has also now fired two top deputies at the Department of Health and Human Services, Heather Flick Melanson, Kennedy’s chief of staff, and Hannah Anderson, deputy chief of staff of policy. Effective immediately, Matt Buckham will now serve as Acting Chief of Staff.
July 10, 2025 | FDA Commissioner Releases Statement on Agency’s Progress in His First 100 Days
In this statement, Dr. Marty Makary outlines some of the highlights of initiatives he has championed in his first 100 days as FDA Commissioner. He states he has prioritized a return to “gold-standard science,” emphasizing transparency, efficiency, and public trust. He introduced sweeping reforms such as removing petroleum-based dyes from foods, modernizing oversight of additives and dietary supplements, increasing transparency by releasing over 200 previously undisclosed regulatory letters, and advancing AI integration through tools like the Elsa chatbot. Additionally, Makary has championed efforts to reduce reliance on animal testing, reform food safety inspections, and promote healthier infant formula options.
July 10, 2025 | FDA Publishes Complete Response Letters (CRLs) for Drugs and Biologics to Increase Transparency
Today FDA published more than 200 decision letters, known as complete response letters (CRLs), issued in response to applications submitted to the FDA for approval of drugs or biological products between 2020 and 2024. By making the CRLs available, the public now has significantly greater insight into the FDA’s decision-making and the most common deficiencies cited that sponsors must address before their application is approved.
This initial batch of published decision letters are associated with since-approved applications and have been redacted for trade secrets and confidential commercial information. The Agency is in the process of publishing additional CRLs from its archives.
June 27, 2025 | FDA Releases Final Guidance on Cybersecurity Recommendations for Medical Devices
On June 26, 2025, FDA released Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. These recommendations are intended to promote consistency, facilitate efficient premarket review, and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats. This guidance also addresses FDA’s recommendations regarding section 524B of the FD&C Act for cyber devices. This document supersedes the final guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” issued September 27, 2023.
June 23, 2025 | Acting CDER Chief Jacqueline Corrigan-Curay Announces Retirement
Endpoints news has reported Jacqueline Corrigan-Curay, who’s been at the FDA’s Center for Drug Evaluation and Research for more than eight years, has announced her retirement in an email to staff, stating that she has decided to retire in July of this year. The publication stated they reviewed the email and confirmed this news with several individuals within the agency.
June 23, 2025 | FDA Releases Draft Guidance: Q1 Stability Testing of Drug Substances and Drug Products
The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance outlines stability data expectations for drug substances and drug products to support drug product marketing, including marketing authorization applications and, where applicable, drug master files. This draft guidance is a consolidated revision of the ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E, and Q5C series of stability guidances, published November 2003, March 1996, May 1997, January 2003, June 2004, and July 1996, respectively. The revision also provides stability related guidance for product categories such as advanced therapy medicinal products, vaccines, and other complex biological products including combination products that were not previously covered under the existing stability guidances. The draft guidance is intended to provide an internationally harmonized approach to conducting and presenting data on stability testing for drug substances and drug products, as well as providing alternative, scientifically justified approaches that may be encountered due to scientific considerations and characteristics of the data being evaluated.
June 19, 2025 | Paula Stannard Appointed Director of HHS Office for Civil Rights
The U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) announces the appointment of Paula M. Stannard as Director of the Office for Civil Rights. In this role, Director Stannard is the Department’s chief officer and adviser to Secretary Robert F. Kennedy, Jr. concerning the implementation, compliance, and enforcement of Federal health information privacy, security, and breach notification rules under the Health Insurance Portability and Accountability Act (HIPAA) as well as Federal civil rights, conscience, and religious freedom laws in HHS’ jurisdiction.
June 18, 2025 | FDA Director of the Office of Cell and Gene Therapy Placed on Administrative Leave
A STAT exclusive article reports that Nicole Verdun, director of the office that reviews cell and gene therapies at the Food and Drug Administration (FDA), and her deputy Rachael Anatol have both been placed on administrative leave as of June 18, 2025.
June 18, 2025 | FDA Pauses Clinical Trials Exporting U.S. Cells Abroad Over Biosecurity Concerns
The U.S. Food and Drug Administration (FDA) has paused all new clinical trials that involve sending American patients’ living cells to foreign laboratories, particularly in countries identified as adversarial (such as China), to undergo genetic manipulation. This action follows concerns that such transfers have occurred without full patient consent or awareness, potentially risking exposure of U.S. biological materials to misuse. The FDA is reviewing these trials under new guidelines requiring transparency, informed consent, and domestic processing of sensitive samples. Trials unable to meet these standards will be rejected.
June 17, 2025 | CDC Reinstates One Third of Staff Laid Off in April’s RIF
The Centers for Disease Control and Prevention (CDC), at a recent all hands meeting on Tuesday, informed staff that they have reinstated approximately one-third of the employees affected by recent layoffs, reflecting a broader trend within the Department of Health and Human Services. In April, the CDC issued reduction-in-force (RIF) notices to 2,400 employees. However, it has since reversed course on roughly 800 of those terminations.
“We’re just really grateful that so many cut staff have been restored,” acting CDC Chief Operating Officer Sara Patterson said during the meeting. “We’re really grateful for all the work that all of you do. I know it’s a difficult time. You’re working without colleagues that you’ve been working with for years and years, and we’ve gone through a lot of change, but I just want you to know how much we appreciate all of you.”
June 17, 2025 | FDA Launches Fast-Track Voucher Program to Accelerate Drug Approvals for National Health Priorities
The U.S. Food and Drug Administration has introduced the Commissioner’s National Priority Voucher (CNPV) program, an initiative aimed at expediting drug approvals for treatments aligned with critical U.S. health interests.
This program enables select companies to receive priority review vouchers, reducing the standard 10–12 month review period to just 1–2 months. Key areas of focus include addressing public health crises, fostering innovative cures, meeting unmet medical needs, and enhancing domestic drug manufacturing for national security.
The CNPV process employs a multidisciplinary, “tumor board-style” review, promoting collaborative and timely decision-making. To qualify, sponsors must submit essential application components, such as the chemistry, manufacturing, and controls (CMC) section and draft labeling, at least 60 days prior to the final submission and maintain active communication with the FDA throughout the review process.
June 16, 2025 | Judge Orders NIH to Restore Diversity-Related Research Grants
A federal judge in Massachusetts on Monday ordered the National Institute of Health (NIH) to restore hundreds of scientific research grants previously ordered to be terminated by the Trump administration, saying the funding cancellations were illegal and discriminatory. Andrew Nixon, a spokesman for the Department of Health and Human Services (HHS), said the agency is exploring its legal options, including moving to stay the judge’s order and launching an appeal.
June 10, 2025 | Makary and Prasad Publish Official Priorities of “New FDA”
Published on JAMA, FDA Commissioner, Dr. Marty Makary, and FDA CBER Director, Dr. Vinay Prasad, developed an article outlining what they consider to the be top priorities of their “new FDA”. The article outlines six priority areas for the FDA: faster approval timelines post-pandemic, modernizing internal culture to support small innovators, integrating AI and digital tools into regulatory review, stronger food oversight with ingredient bans and clearer labeling, broader use of real-world evidence over multiple randomized trials, and enhancing drug affordability through faster generic approvals. The overall aim is to transform the FDA into a more agile, prevention-oriented agency while preserving public trust.
June 10, 2025 | FDA Brings Back Previously Disbanded Generic Drug Policy Office
It’s been reported that the FDA has reestablished the Generic Drug Policy Office, which was previously dissolved during the widespread layoffs carried out by HHS earlier this year. As reported by Endpoints, the rationale for reinstating the office and the number of returning former staff remain uncertain, according to two anonymous FDA sources familiar with the matter. However, one of the sources noted that some of the laid-off employees had already returned to the FDA’s Maryland campus on Monday.
June 10, 2025 | Makary Says He Wasn’t Consulted Prior to ACIP Staff Removal
In exclusive comments made to ENDPOINTS News following the removal of all 17 members of HHS’s ACIP committee, Makary stated he wasn’t involved in HHS Secretary Robert F. Kennedy Jr.’s decision. ENDPOINTS then asked whether the FDA is planning a similar overhaul of its own vaccine advisory committee, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), to which Makary replied that would be up to new CBER chief Vinay Prasad.
June 9, 2025 | HHS Removes all 17 Members of CDC’s Vaccine Advisory Committee
In a press release posted by HHS, it was today announced that “Under the leadership of HHS Secretary Robert F. Kennedy, Jr., the agency removed the 17 sitting members of the ACIP committee and will replace them with new members currently under consideration.”
The Advisory Committee for Immunization Practices (ACIP) is responsible for making recommendations on the safety, efficacy and clinical need of vaccines.
“A clean sweep is needed to re-establish public confidence in vaccine science,” Kennedy wrote in an opinion piece published by the Wall Street Journal.
Following the press release on Tuesday night, Kennedy released a detailed post of the action on X, elaborating on the move and saying he “will use this platform to announce new members to populate ACIP.”
June 6, 2025 | FDA Updates Tobacco Product Application Forms – Must be Used by July 6
On June 6, 2025, FDA posted six updated or new forms that are required for submitting new tobacco product applications under the premarket tobacco product application (PMTA) and Substantial Equivalence (SE) pathways. Starting July 6, 2025, applicants must use these forms in their PMTA and SE Report submissions. If applicants do not use the latest version of the forms or do not complete them properly, FDA generally intends to refuse to accept the application.
- Form FDA 4057 – Premarket Tobacco Product Application (PMTA) Submission
- Form FDA 4057a – Premarket Tobacco Product Application Amendment and General Correspondence Submission
- Form FDA 4057b – PMTA Unique Identifying Information for New Tobacco Products (formerly referred to as a grouping spreadsheet)
- Form FDA 3965 – Tobacco Substantial Equivalence Report Submission
- Form FDA 3965a – Tobacco Substantial Equivalence Report Amendment and General Correspondence Submission (formerly Form FDA 3964)
- Form FDA 3965b (NEW) – SE Unique Identifying Information for New Tobacco Products
June 5, 2025 | Makary Discusses Ways to Speed Drug Approvals and Reduce User Fees
ENDPOINTS News recently reported FDA commissioner Marty Makary has been making numerous comments in recent public events around his goals for the future of the biopharma industry. In their article, they reported that at a recent FDA roundtable on cell and gene therapies, Makary mentioned, when discussing shortening the overall drug application process timeline: “We are taking a look at the application process. We’re asking ourselves: Can certain materials be submitted in advance so approvals can be quicker? Can we use post-approval monitoring and the assurance of post-approval monitoring in the actual decision-making process?”
Later that week at an investor event hosted by Jeffries, Makary stated “I would like to see lower user fees,” further stating “there are a lot of benefits to lower user fees, and I think it’s something we’re going to talk about.”
June 2, 2025 | FDA Launches “Elsa”, an Agency-Wide Ai Tool to Boost Efficiency
The U.S. Food and Drug Administration (FDA) today launched Elsa, a large language model–powered AI tool designed to assist with reading, writing, and summarizing for FDA review teams in an effort to boost efficiency.
Built within a high-security GovCloud environment, Elsa offers a secure platform for FDA employees to access internal documents while ensuring all information remains within the agency. The agency claims the models do not train on data submitted by regulated industry, safeguarding the sensitive research and data handled by FDA staff.
A few examples of how the agency intends to use Elsa include summarizing adverse events to support safety profile assessments, performing faster label comparisons, and generating code to help develop databases for nonclinical applications. The agency is already using Elsa to accelerate clinical protocol reviews, shorten the time needed for scientific evaluations, and identify high-priority inspection targets.
These are only the first introduced use cases. As the tool matures, the agency has plans to integrate more AI in different processes, such as data processing and generative-AI functions to further support the FDA’s mission. “As we learn how employees are using the tool, our development team will be able to add capabilities and grow with the needs of employees and the agency.” – FDA Chief AI Officer Jeremy Walsh
May 22, 2025 | FDA Takes Action to Address Data Integrity Concerns with Two Third-Party Testing Firms
The U.S. Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) issued General Correspondence Letters to two third-party testing companies in China after discovering data that was falsified or otherwise found to be invalid.
The General Correspondence Letters were sent to Mid-Link Technology Testing Co., Ltd.(“Mid-Link”) in Tianjin, China, and Sanitation & Environment Technology Institute of Soochow University Ltd. (dba “SDWH”) in Suzhou, China. The letters stated in part, that because the FDA could not ensure the reliability and validity of biocompatibility testing and animal safety and performance testing studies conducted at their respective testing facilities, the agency will reject those testing facilities’ data generated for use in premarket device submissions.
“Let me be clear. The FDA has no room for bad actors. Once we discover data integrity issues, we will respond accordingly,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Such false and shoddy activity jeopardizes access to new devices for patients and healthcare providers, negatively impacts product sponsors, and potentially disrupts the medical device supply chain.”
May 22, 2025 | FDA and CBP Seize Nearly $34 Million in Illegal E-Cigarettes During Joint Operation
On May 22, the U.S. Food and Drug Administration (FDA) announced in an official press release that they conducted a joint initiative with Customs and Border Protection (CBP) that led to the seizure of nearly two million units of unauthorized e-cigarette products in Chicago, with an estimated retail value of $33.8 million. The seizures, which occurred in February of this year, were part of a joint federal operation to examine incoming shipments and prevent illegal e-cigarettes from entering the country.
Per the release, “during this operation, the team uncovered shipments of various illegal e-cigarette products, almost all of which originated in China and were intended for shipment to various U.S. states. FDA and CBP personnel determined that, in an apparent attempt to evade duties and the review of products for import safety concerns, many of these unauthorized e-cigarette shipments contained vague product descriptions with incorrect values. Upon examining shipments, the team found several brands of unauthorized e-cigarettes, including Snoopy Smoke, Raz, and others.”
May 20, 2025 | FDA Names Elizabeth Miller Pharm.D. Acting Associate Commissioner – Office of Inspections and Investigations
According to the biography listed on the FDA website, Dr. Miller most recently served as Deputy Associate Commissioner for Medical Products, overseeing OII’s Medical Products Inspectorate. Combined with her prior position as the Assistant Commissioner for Medical Products and Tobacco Operations, Dr. Miller has managed large volumes of FDA inspections relating to drugs, medical devices, biologics, bioresearch monitoring, and tobacco products. Her extensive background includes executive leadership at U.S. Pharmacopeia, where she helped shape regulatory science collaboration, public policy, and governmental affairs while working alongside federal agencies, industry leaders, and international regulators.
May 20, 2025 | FDA Names Dr. Bret Koplow as Head of Center for Tobacco Products
Today the FDA announced they have named Dr. Bret Koplow as the new head of the Agency’s Center for Tobacco Products. Dr. Koplow had served as Senior Counselor to the Commissioner in the Immediate Office of the Commissioner since early 2020, where he has focused principally on regulatory, policy, and operational matters involving CTP, including work on e-cigarettes, cigars and other tobacco products. Before joining the Commissioner’s Immediate Office, he served as Senior Counsel in the FDA’s Office of the Chief Counsel, and before that he served in the FDA’s Office of Legislation as the Senior Advisor for Oversight.
In this position, Dr. Koplow is responsible for assuring that CTP accomplishes its public health goals and for operationalizing the Center’s vision and mission as it implements the Family Smoking Prevention and Tobacco Control Act.
May 16, 2025 | FDA Clears First Blood Test Used in Diagnosing Alzheimer’s Disease
The U.S. Food and Drug Administration today cleared for marketing the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is for the early detection of amyloid plaques associated with Alzheimer’s disease in adult patients, aged 55 years and older, exhibiting signs and symptoms of the disease. The new test provides a less invasive option to current methods, reducing reliance on PET scans and increases diagnosis accessibility.
May 15, 2025 | FDA Announces Post-Market Chemical Review Program for Chemicals Used in U.S. Food Supply
The U.S. Food and Drug Administration (FDA) is implementing a more structured and transparent system to review the safety of chemicals already used in the U.S. food supply. This marks a shift from the agency’s previous approach, which primarily relied on responding to individual petitions or new scientific findings.
Key actions the FDA plans to take include:
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Developing a modernized, evidence-based method to prioritize which food chemicals to review.
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Establishing a systematic post-market review process, which will be informed by public and stakeholder input.
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Updating the list of chemicals under review, with specific focus on substances such as BHT, BHA, ADA, phthalates, propylparaben, and titanium dioxide.
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Committing to greater transparency by regularly sharing updates on the FDA’s public website.
These efforts are part of a broader initiative to enhance oversight of food chemicals. Recent related steps by the FDA include:
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Announcing the planned phase-out of petroleum-based synthetic dyes.
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Considering changes to the GRAS (Generally Recognized as Safe) process, potentially ending the practice of companies independently declaring substances safe without FDA review.
The goal of the initiative is to strengthen food safety oversight through proactive, science-based policies that improve public trust and support informed consumer choices.
May 13, 2025 | FDA to Remove Ingestible Fluoride Prescription Drug Products for Children from the Market
The U.S. Food and Drug Administration (FDA) today announced that it is initiating action to remove concentrated ingestible fluoride prescription drug products for children from the market. Unlike toothpaste with fluoride or fluoride rinses, the products the agency will be taking action against are meant to be swallowed and ingested.
The agency has set a goal date of October 31, 2025 for completing a safety review and public comment period and for taking appropriate action regarding removal of these products from the market.
May 13, 2025 | HHS/FDA Initiate Comprehensive Review of Infant Formula
The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) today announced the next steps in Operation Stork Speed, an initiative to ensure the safety, reliability, and nutritional adequacy of infant formula. The FDA issued a Request for Information (RFI) to begin the nutrient review process required by law for infant formula. Currently, infant formula must meet minimum and maximum levels of certain nutrients. While the FDA regularly reviews individual nutrient requirements for infant formula, this will be the first comprehensive review since 1998.
Through the RFI, the FDA is seeking public input to help determine whether existing nutrient requirements should be revised based on the latest scientific data, including international. The agency also welcomes data on potential adjustments to existing minimum or maximum levels, recommendations for additional nutrients to consider, and how such changes may improve health outcomes.
Commenters will have 120 days to submit responses. Further information on how to submit a comment can be found here.
May 13, 2025 | HHS/FDA Issue RFI on Deregulatory Plan
The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) today announced the launch of a public Request for Information (RFI) to identify and eliminate outdated or unnecessary regulations. The initiative is part of a broader federal effort to reduce regulatory burdens in alignment with President Trump’s Executive Order 14192.
In their press release, HHS stated that under the Executive Order, HHS will implement the following measures:
- The 10-to-1 rule: For every new regulation introduced, at least ten existing regulations must be eliminated.
- Regulatory cost cap: The total cost of all new regulations in fiscal year 2025 must be significantly less than zero.
- Expanded scope: The order applies not only to formal regulations but also to guidance documents, memoranda, policy statements, and similar directives.
- Radical transparency: HHS will publish annual reports detailing estimated regulatory costs and the specific rules being offset, promoting greater transparency and accountability.
May 12, 2025 | Trump Signs Executive Order to Reduce Prescription Drug Prices for American Consumers
On May 12, 2025, President Trump signed an Executive Order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients”. The presidential action outlines a policy directing federal agencies to ensure Americans do not pay more for prescription drugs than the lowest price available in other economically comparable countries (a “most-favored-nation” price). It emphasizes lowering drug prices through direct-to-consumer models, international trade negotiations, and executive coordination to stop U.S. consumers from subsidizing foreign drug markets. The primary actions outlined in this policy include:
Most-Favored-Nation Pricing Standard
Directs the Secretary of Health and Human Services (HHS) to ensure that American consumers do not pay more for prescription drugs than the “most-favored-nation price,” defined as the lowest price charged in an OECD country with comparable per-capita GDP.
Direct Purchase Mechanisms
Instructs the HHS Secretary to consider actions that allow patients to purchase prescription drugs directly from manufacturers at or below the most-favored-nation price.
Trade and Commerce Review
Calls on the Secretary of Commerce and the U.S. Trade Representative to identify foreign government policies that pressure manufacturers to provide artificially low prices abroad, shifting disproportionate costs to U.S. consumers, and to recommend appropriate actions.
Coordination Across Agencies
Requires coordination between HHS, Commerce, USTR, and other relevant federal agencies to support the implementation of the policy objectives.
May 9, 2025 | NIH & FDA Announce Launch of New Joint “Nutrition Regulatory Science Program”
Under the new Nutrition Regulatory Science Program, the FDA and NIH will launch a comprehensive research initiative to inform effective food and nutrition policy. The FDA will contribute regulatory science expertise, while the NIH will manage research solicitation, review, and oversight. According to the agencies, this cross-disciplinary effort will involve experts in chronic disease, nutrition, toxicology, risk analysis, behavioral science, and chemistry. While a formal research agenda has yet to be established, both organizations have emphasized their commitment to conducting fair, independent, and conflict-free research.
May 9, 2025 | FDA Approves Three Food Colors From Natural Sources
The U.S. Food and Drug Administration today announced it granted three new color additive petitions that will expand the palette of available colors from natural sources for manufacturers to safely use in food.
The color additive petitions approved are for:
- Galdieria extract, a blue color derived from the unicellular red algae Galdieria sulphuraria. The FDA has approved the color additive for use in nonalcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milk shakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candy, soft candy and chewing gum, flavored frostings, ice cream and frozen dairy desserts, frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, and whipped cream, yogurt, frozen or liquid creamers (including non-dairy alternatives), and whipped toppings (including non-dairy alternatives). The petition was submitted by the French company Fermentalg.
- Butterfly pea flower extract, a blue color that can be used to achieve a range of shades including bright blues, intense purple, and natural greens. Produced through the water extraction of the dried flower petals of the butterfly pea plant, this color additive is already approved for use in sport drinks, fruit drinks, fruit and vegetable juices, alcoholic beverages, dairy drinks, ready to drink teas, nutritional beverages, gums, candy, coated nuts, ice creams, and yogurt. Today’s approval of a petition by St. Louis-based Sensient Colors LLC expands the approved use for coloring ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), plain corn chips, tortilla chips, and multigrain chips.
- Calcium phosphate, a white color approved for use in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies. The petition was filed by Innophos Inc. of Cranbury, New Jersey.
May 7, 2025 | FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline
FDA Commissioner Dr. Martin Makary, today announced an aggressive timeline to scale use of artificial intelligence (AI) internally across all FDA centers by June 30, 2025, following the completion of a new generative AI pilot for scientific reviewers. Dr. Makary has directed all FDA centers to begin deployment immediately, with the goal of full integration by the end of June. Work will continue to expand use cases, improve functionality and adapt to the evolving needs of each center after June 30. By that date, all centers will be operating on a common, secure generative AI system integrated with FDA’s internal data platforms.
May 6, 2025 | FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities
While FDA commissioner Dr. Marty Makary had previously touched on this initiative in his interview with Megyn Kelly a few weeks ago, the agency has today formally announced their intent to expand the use of announced inspections at foreign manufacturing facilities of food, medicine, and medical products intended for American consumers. This change builds upon the agency’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program in India and China and aims to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies. In addition, the FDA will evaluate the agency’s policies and practices for improvements to the foreign inspection program.
May 6, 2025 | FDA Names First AI Chief
Jeremy Walsh announced on Linkedin that he is starting a new position as Head of IT and AI at the U.S. FDA, a newly developed position at the agency. Politico reports that Walsh comes from the government contractor Booz Allen Hamilton, where he worked for 14 years and was chief technologist, building out cloud networks and data analytics systems for the agencies the firm works with. His work included contracts with the FDA, the CDC, the NIH, Veterans Affairs and military health services.
May 6, 2025 | FDA Commissioner Selects Dr. Vinay Prasad to Head CBER
Today FDA commissioner Dr. Marty Makary announced his pick for Director of the Center for Biologics Evaluation and Research (CBER) as Dr. Vinay Prasad.
Dr. Prasad is a hematologist-oncologist and Professor in the Department of Epidemiology and Biostatistics at the University of California San Francisco, is recognized for his critical perspectives on pharmaceutical industry practices and certain public health policies, including skepticism about COVID-19 vaccine mandates for children. His appointment has elicited mixed reactions: some stakeholders express concern over potential regulatory tightening and its impact on vaccine approvals, while others, including FDA Commissioner Dr. Marty Makary, commend his commitment to scientific rigor and independent analysis.
May 5, 2025 | Trump Signs Executive Order to Increase U.S. Pharmaceutical Manufacturing
On May 5, 2025, President Donald Trump signed an executive order aimed at bolstering domestic pharmaceutical manufacturing by reducing regulatory barriers and expediting facility approvals. The order directs the FDA to streamline approval processes for domestic plants and increase oversight of foreign manufacturing facilities, including implementing more frequent surprise inspections and higher fees.
The Environmental Protection Agency is also instructed to expedite the permitting process for constructing facilities that produce prescription drugs and active pharmaceutical ingredients. This initiative is part of a broader strategy to reduce U.S. reliance on foreign sources for essential medical supplies, citing national security concerns.
Industry responses have been mixed. While some pharmaceutical companies, like Bristol Myers Squibb, have announced significant investments in U.S. manufacturing in response to these policy shifts, others express concern over potential disruptions to the global supply chain.
The executive order represents a significant policy shift aimed at strengthening domestic pharmaceutical manufacturing. Its long-term impact on the industry and global supply chains will depend on its implementation and the response from various stakeholders.
May 5, 2025 | In Reversal, FDA Rehiring Some Staff Affected by Earlier Mass Layoffs
Multiple reports have been posted over the past few days of instances where the Agency has begun sending out notices to previously terminated employees, rescinding those terminations and reinstating their employment, effective immediately.
Workers who process records about medical device and tobacco regulation under the Freedom of Information Act received notices from an FDA official May 1 that they were no longer being fired as part of the department’s mass layoffs. Also on May 1, it was reported that the Agency would be reinstating more than 20 of the agency’s roughly 60 travel staff that had been previously terminated; these employees had been responsible for handling travel bookings for FDA safety inspectors. Additionally, on May 5, it was reported that the agency is rehiring at least one user fee negotiator and nine other employees who supported user fee processes, according to two anonymous sources familiar with the matter.
May 1, 2025 | HHS/NIH Launch Next Generation Universal Vaccine Platform for Pandemic-Prone Viruses
The U.S. Department of Health and Human Services (HHS) and the National Institutes for Health (NIH) today announced the development of the next-generation, universal vaccine platform, Generation Gold Standard, using a beta-propiolactone (BPL)-inactivated, whole-virus platform.
This initiative funds the NIH’s in-house development of universal influenza and coronavirus vaccines, including candidates BPL-1357 and BPL-24910. These vaccines aim to provide broad-spectrum protection against multiple strains of pandemic-prone viruses like H5N1 avian influenza and coronaviruses including SARS-CoV-2, SARS-CoV-1, and MERS-CoV.
Clinical trials for universal influenza vaccines are scheduled to begin in 2026, with FDA approval targeted for 2029. The intranasal BPL-1357 flu vaccine, currently in advanced trials, is also on track for FDA review by 2029.
April 30, 2025 | FDA to Require Placebo Testing for All New Vaccines
The US Department of Health and Human Services said it will require that all new vaccines be tested in placebo-controlled trials before they’re licensed for use. “Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure—a radical departure from past practices,” the Department of Health and Human Services (HHS) said in a statement to CNN.
April 30, 2025 | FDA Names Craig Taylor as Acting Chief Information Officer (CIO)
“Craig Taylor has been named the Acting Chief Information Officer (CIO) at the U.S. Food and Drug Administration. In this role Mr. Taylor sets and leads the agency’s Information Technology (IT) strategy, as well as the agency’s enterprise IT, data management, and cybersecurity within the Office of Digital Transformation. Prior to being named acting CIO, Mr. Taylor served as the FDA’s Chief Information Security Officer, since 2015, directing and leading the FDA Cybersecurity, Counterintelligence, and Insider Threat Program to ensure security controls are appropriately applied to FDA IT systems to protect the confidentiality, integrity, and availability of data and sensitive information.” – FDA.gov/about-fda
April 30, 2025 | Dr. Timothy Schell Named FDA Acting Director for the Center for Veterinary Medicine (CVM)
“Timothy C. Schell, Ph.D., is the Acting Director for the Center for Veterinary Medicine (CVM) at the U.S. Food and Drug Administration. CVM regulates animal food, drugs, and devices, including those intended for pets as well as the animals that produce the meat, milk and eggs for human consumption. Most recently, Dr. Schell led CVM’s Office of Surveillance and Compliance”. FDA.gov/about-fda
April 30, 2025 | Lowell Zeta Named FDA Deputy Commissioner for Strategic Initiatives
“Lowell M. Zeta, J.D., has been named as Deputy Commissioner for Strategic Initiatives at the U.S. Food and Drug Administration. Mr. Zeta is responsible for collaborating with the FDA Commissioner to identify opportunities to improve regulatory programs, to develop innovative strategies to emerging and ongoing issues, and to implement new programs and solutions to achieve the FDA’s mission objectives. He works closely with FDA senior leadership and provides executive oversight for operations and regulatory process improvements associated with drugs and biologics, devices and diagnostics, veterinary medicine, human foods, and tobacco products. His responsibilities include driving change, overseeing change management, and ensuring the alignment of the key functions of strategy planning. He serves as the point-person to assess whether strategic initiatives, at all levels of the organization, are in line with the Commissioner’s priorities and the broader goals of the U.S. Department of Health and Human Services and the Administration.” – FDA.gov/about-fda
April 29, 2025 | FDA Has No Plan to Reorganize Product Sectors. Makary Says in Interview “I Rejected That Proposal”
In an exclusive interview with Inside Medicine, FDA Commissioner Dr. Marty Makary was asked if there were any plans for reorganization within the FDA centers. Makary responded “No. There will not be a reorganization. Yes, we are consolidating travel offices, IT, and some other things that make sense for efficiency, but nothing else is planned. A proposal for reorganization came from some staff, but I rejected that proposal.”
April 29, 2025 | FDA Commissioner Says They Are Looking at Whether They Will Approve Covid-19 Vaccines for Next Winter
In a recent CBS Interview, Dr. Makary commented on the delay of the Novavax COVID-19 non-MRNA vaccine, currently delayed from its original target date for permanent approval of April 1. Makary mentioned outdated data as one of the reasons for the delay, stating the last study the agency has that shows a clinical benefit for this product was in 2021, and the study excluded individuals with prior COVID-19 infection, which does not properly reflect the state of the general US population in 2025. Makary stated he felt that, for not just COVID vaccines but for drugs in general, the agency should reevaluate if these products are still effective today under the US’s current conditions, and that evaluation needs to be seen before the agency would be comfortable recommending these products for public use. When asked if the agency would be approved COVID-19 booster shots for next winter, Makary responded that he would not comment on any particular application, but they would be “taking a look”, further saying he needs to see “good data” rather than “opinions” to fully make this decision.
April 28, 2025 | HHS/NIH Posts First Two SBIR Solicitations Since Grant Freeze in January
The U.S. Department of Health and Human Services with the National Institute of Health today published two official solicitations for Small Business Innovation Research (SBIR) funding opportunities. These are the first two solicitations the agency has published since January of this year.
Topics include:
April 22, 2025 | HHS to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food Supply
The U.S. Department of Health and Human Services and U.S. Food and Drug Administration (FDA) today announced a series of new measures to phase out all petroleum-based synthetic dyes from the nation’s food supply.
The FDA is taking the following actions:
- Establishing a national standard and timeline for the food industry to transition from petrochemical-based dyes to natural alternatives.
- Initiating the process to revoke authorization for two synthetic food colorings—Citrus Red No. 2 and Orange B—within the coming months.
- Working with industry to eliminate six remaining synthetic dyes—FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2—from the food supply by the end of next year.
- Authorizing four new natural color additives in the coming weeks, while also accelerating the review and approval of others.
- Partnering with the National Institutes of Health (NIH) to conduct comprehensive research on how food additives impact children’s health and development.
- Requesting food companies to remove FD&C Red No. 3 sooner than the 2027-2028 deadline previously required.
April 22, 2025 | Reports Claim Dr. Marty Makary Announced Three New Hires in FDA Leadership Team
According to an email reportedly sent to FDA staff on Monday, the new arrivals include Lowell Zeta as Deputy Commissioner for Strategic Initiatives; Timothy Schell as Acting Director for the Center for Veterinary Medicine; and Craig Taylor as the Acting Chief Information Officer. The FDA website has not yet been updated to confirm this report.
Update: On April 30, 2025, FDA’s website was updated, confirming this report.
April 19, 2025 | Dr. Marty Makary Announces Increase in Inspections for Overseas Manufacturers and Future Changes to Pharmaceutical Advertising
Today a bonus segment was released from Dr. Makary’s interview with the Megyn Kelly Show. In the segment, Dr. Makary announced the FDA’s plan to increase inspection teams of foreign manufacturers, especially manufacturers of pharmaceuticals, as well as increase the number of unscheduled, surprise inspections of those manufacturing facilities.
Additionally, Makary mentioned the Agency is “looking into” drug advertisements on television, specifically at how the infromation is presented. He said that while the Agency has no plan to outright ban TV advertising for pharmaceuticals, they are exploring additional regulations to ensure the information presented provides consumers with the “full picture”.
April 18, 2025 | Dr. Lilliam Rosario, Director of CDER’s Office of Computational Science, Announces Departure from FDA
Today on Linkedin, Dr. Lilliam Rosario announced her departure from the Agency. In her announcement, Dr. Rosario stated “After almost 25 years at the FDA, I have made the difficult decision to step away. My final day with the Agency was April 18. While this marks the end of my role at the FDA, I remain committed to the principles and collaborations that have defined my time at FDA. More than ever, we must be stewards to the principles of science.”
April 18, 2025 | FDA Commissioner Marty Makary Shares Agency Insights and Policy Updates in Interview with Megyn Kelly
In an interview with Megyn Kelly, Dr. Makary provided insights into his priorities for the agency and policy shifts under the new administration:
- Policy Update: Dr. Markary announced a new policy intended to limit conflicts of interest within pharmaceutical review boards. While Dr. Makary noted that industry’s feedback and input is important, he emphasised “the scientific evaluation needs to be independent”. Under the new policy, FDA intends to remove pharmaceutical industry members from FDA Advisory Committees and replace them “whenever statatoraly possible with patients and family caregivers”. Industry represnetatives will still be invited to advisory committees, but will “sit with the rest of the public”.
- Agency Priorities:
- Addressing Chronic Diseases and Public Health: He emphasized the need to tackle the rise of chronic diseases in the U.S., advocating for a shift from merely treating symptoms with medications to addressing underlying causes, including examining root causes for conditions such as autism and diabetes.
- Promoting an Apolitical FDA: Dr. Makary stressed that public health should transcend political affiliations. He highlighted initiatives like revising nutrition guidelines and evaluating food additives as nonpartisan efforts aimed at enhancing public health, and noted that we could expect action on this in the coming weeks.
- Expediting Review Processes: He also highlighted the importance of expediting the process of approving medications that can help treat chonic conditions in cases where medication is necessary, touching on removing burdensome requirements, such as animal testing, to speed up the approval process. He also mentioned they would be bringing in a team to introduce Ai into the review process to streamline Reviewer workflows and streamline the review process.
- Insights Into Staff Cuts: Dr. Makary said there are no further plans for mass staff cuts to the agency, noting that in the previous cuts were focused around reducing staff in administrative areas and “there were no cuts to scientists, reviewers, inspectors, or law enforcement at the FDA and my goal is to make sure that all of those people have the resources they need to do their job well”.
April 17, 2025 | FDA Commissioner Marty Makary Announces New Policy on Individuals Serving on FDA Advisory Committees
Today the FDA issued a press release, announcing a policy directive that limits individuals employed at companies regulated by the U.S. Food and Drug Administration, such as pharmaceutical companies, from serving as official members on FDA advisory committees, where statutorily allowed. As part of this effort, the agency will prioritize and elevate the role of patients and caregivers, strengthening the voices of their communities.
Today’s action will not preclude employees of regulated companies from attending or presenting their views at advisory committee meetings or serving as representative members of the committee when required by statute. Also, exceptions can be made in rare circumstances (i.e., when the scientific expertise in an area is only available from an employee of an FDA-regulated company) provided that the official strictly complies with the applicable ethics requirements.
By limiting employees of FDA-regulated companies from serving as officials, the FDA aims to boost public trust in its decisions and improve how its advisory committees operate.
April 15, 2025 | FDA Names Grace Graham as Deputy Commissioner for Policy, Legislation, and International Affairs.
In this role, Grace Graham will lead the Office of Policy, Legislation, and International Affairs (OPLIA), which serves as the FDA’s focal point for engagement with the U.S. Congress, the Administration, global counterparts and partners, and state, local, territorial, and tribal policymakers.
April 11, 2025 | FDA Welcomed HHS Secretary Robert F. Kennedy, Jr. to FDA Campus
The U.S. Food and Drug Administration welcomed HHS Secretary Robert F. Kennedy, Jr. to its headquarters in Silver Spring, Maryland, a visit that included remarks to FDA employees, meetings with agency leadership, and a tour of several medical device innovation laboratories on the FDA’s White Oak campus.
April 10, 2025 | FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs
Today, the U.S. Food and Drug Administration is taking a groundbreaking step to advance public health by replacing animal testing in the development of monoclonal antibody therapies and other drugs with more effective, human-relevant methods. The new approach is designed to improve drug safety and accelerate the evaluation process, while reducing animal experimentation, lowering research and development (R&D) costs, and ultimately, drug prices.
April 2, 2025 | FDA Names Dr. Scott Steele as Acting Director – Center for Biologics Evaluation and Research (CBER)
On April 2, the FDA named Scott Steele Ph.D. as the new Acting Director of CBER following Dr. Peter Marks’ resignation. Dr. Steele moved into this executive role after serving as Senior Advisor for Translational Science in CBER’s Office of Center Director where he advanced horizon scanning and translational science programs, external partnerships, and policy initiatives in areas such as artificial intelligence and cellular and gene therapies.
April 2, 2025 | FDA Officially Welcomes Dr. Marty Makary as 27th Commissioner in First Public Address to Staff
On April 2, the FDA welcomed Dr. Marty Makary as the 27th commissioner of the Food and Drug Administration. In Dr. Makary’s first public address to staff, he stated his goal is to ensure the FDA upholds the gold standard of trusted science, transparency and common sense to rebuild public trust and advance health and safety in the US and around the world.
April 2, 2025 | Supreme Court Rules in Favor of FDA in its Dispute Over Non-Tobacco Flavored ENDS Products
Wednesday, the Supreme Court unanimously ruled to throw out a federal appeals court ruling that found the agency unlawfully changed the rules in the middle of proceedings when it was deciding whether to approve various tobacco harm reduction products. Writing on behalf of the unanimous court, Justice Samuel Alito stopped short of ruling definitively on one particular aspect of the case: whether the agency should have considered the companies’ marketing plans as part of the approval process. This remaining issue has been directed to be decided by a lower court.
Ultimately, this ruling may not be the final word in the case and the FDA could change its approach under the new administration, especially in light of President Donald Trump’s promise to “save” this product category.
April 1, 2025 | Matthew Farrelly, Director of Science at CTP, Reassigned
Today Matthew Farrelly, Director of Science at the FDA’s Center for Tobacco Products (CTP), announced on Linkedin that he has been reassigned outside of CTP as part of the Department of Health and Human Services (HHS) restructuring, and will now be working elsewhere within HHS.
April 1, 2025 | The US Senate HELP Committee Formally Requests RFK Jr. to Speak at Hearing Regarding HHS Restructuring Plans
Today the US Senate Committee on Health, Education, Labor, and Pensions (HELP) formally requested HHS Secretary, Robert F. Kennedy, Jr, to speak at a hearing titled “An Update on the Restructuring of the Department of Health and Human Services.” The hearing will discuss his proposed reorganization of the Department of Health and Human Services.
April 1, 2025 | Dr. Brian King, Director of CTP, Placed on Administrative Leave
Following HHS’s previously announced restructuring plan, Dr. Brian King, Director of the FDA’s Center for Tobacco Products (CTP), was removed from his position and placed on administrative leave immediately. According to an Associated Press Report, he has been offered reassignment to the Indian Health Service. In addition to the removal of King from his position, there have also been reports that dozens of CTP staff, including teams responsible for regulation and policy, have also been dismissed as part of the restructuring initiative. There is no information on who FDA commissioner, Dr. Marty Makary, will be selecting to replace King as Director of CTP at this time.
April 1, 2025 | FDA, CDC, and Other Health Agencies Begin Layoffs Per HHS Restructuring Plan
Following HHS’s previously announced restructuring plan, layoffs at the FDA, CDC, and other health agencies began on Tuesday. Health Secretary Robert F. Kennedy Jr. has stated the cuts, combined with other recent departures, will reduce total headcount across all HHS departments from 82,000 from 62,000, with 3,500 cuts planned for the FDA. The HHS has stated that the decrease in staff at the FDA is being conducted with a focus on streamlining operations and centralizing administrative functions.
March 31, 2025 | Texas Judge Strikes Down FDA Laboratory Developed Test Final Rule
Today a Texas judge ruled to vacate and set aside the 2024 FDA Final Rule: Medical Devices; Laboratory Developed Tests, which directed for laboratory-developed tests (LDTs) to be regulated as medical devices, with phased compliance deadlines set to begin in May of 2025.
The ruling determined that the FDA’s regulatory action exceeded its authority under current law, remanding the matter to the Secretary of Health and Human Services for further consideration. With this ruling, LDTs will no longer need to meet the upcoming regulatory requirements specified in the FDA final rule.
March 31, 2025 | FDA CDRH Releases Final Guidance Document: Evaluation of Sex-Specific Data in Medical Device Clinical Studies
This document provides guidance on the study and evaluation of sex-specific data in medical device clinical studies. The purpose of this guidance is to outline the FDA’s expectations regarding sex-specific patient enrollment, data analysis, and reporting of study information. The primary intent is to improve the quality and consistency of available data regarding the performance of medical devices in both sexes by encouraging appropriate enrollment by sex in clinical studies of devices, and that data from such studies is appropriately analyzed by sex. This information can be of benefit to patients and their medical providers, as well as clinical researchers and others.
March 28, 2025 | Dr. Kaveeta Vasisht Named Associate Commissioner for Women’s Health at FDA
Dr. Kaveeta Vasisht is responsible for directing the Office of Women’s Health (OWH) at the FDA through scientific programs, research, education and outreach efforts. Prior to joining the Office of Women’s Health, Dr. Vasisht served as the Deputy Director for the Division of Clinical Trial Quality in the Office of Medical Policy in the Center for Drug Evaluation and Research.
March 28, 2025 | Dr. Peter Marks, Director of CBER, Resigns
Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research (CBER), submitted his resignation, effective April 5, 2025, citing disagreement with Health and Human Services Secretary Robert F. Kennedy Jr.
March 27, 2025 | HHS Announces Restructuring Plan, Including Reductions to FDA
RFK Jr. announced Thursday his plan for aligning the Department of Health and Human Services (HHS) with President Trump’s Executive Order, “Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative.” The plan to restructure the HHS combines personnel cuts, centralization of functions, and consolidation of divisions across all departments under HHS. Per the announcement, FDA will decrease its workforce by approximately 3,500 full-time employees, with a focus on streamlining operations and centralizing administrative functions. This reduction will not affect drug, medical device, or food reviewers, nor will it impact inspectors.
March 26, 2025 | Dr. Marty Makary Confirmed US FDA Commissioner
Dr. Marty Makary, a former surgical oncologist and health policy researcher from Johns Hopkins, was confirmed Tuesday night by the U.S. Senate as the next commissioner of the U.S. Food and Drug Administration (FDA) with a 56-44 vote.
March 26, 2025 | Barclay Butler, M.B.A., Ph.D. Named FDA’s Deputy Commissioner for Operations and Chief Operating Officer
In this role, Dr. Butler has leadership authority over the management of business programs and operations across the FDA enterprise level, including human resources and facilities.
March 21, 2025 | Benjamin D. Moncarz Named FDA’s Chief Financial Officer (CFO)
Benjamin D. Moncarz was named Chief Financial Officer – Office of Finance, Budget, Acquisistions and Planning at the US FDA. In this role, Moncarz will have oversight over budget, acquisitions, and financial management at the Agency.
March 20, 2025 | FDA Intends to Extend Compliance Date for Food Traceability Rule
Today, the U.S. Food and Drug Administration (FDA) is announcing its intention to extend the compliance date for the Food Traceability Rule (the “final rule”) by 30 months. The FDA intends to extend the compliance date using appropriate procedures at a later time, including publishing a proposed rule in the Federal Register.
March 13, 2025 | Dr. Marty Makary Nomination Advances
The Senate Health, Education, Labor, and Pensions (HELP) Committee advanced Dr. Makary’s nomination to the full Senate with a 14-9 vote.
March 6, 2025 | Dr. Marty Makary Nomination Hearing
Dr. Marty Makary appeared before the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) for his nomination hearing as FDA Commissioner.
February 28, 2025 | Kyle Diamantas Named as new Acting Deputy Commissioner for Human Foods
U.S. Food and Drug Administration has announced food and beverage attorney Kyle Diamantas is the new acting deputy commissioner for human foods. He replaces Jim Jones, who resigned last week.
February 27, 2025 | FDA Cancels Vaccine Advisory Committee Meeting on 2025-2026 Flu Vaccine
CIDRAP News reported the Agency confirmed the the meeting cancellation with them via email. “A planned March 13 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee on the influenza vaccine strains for the 2025-2026 influenza season in the northern hemisphere has been cancelled,” the agency said. “The FDA will make public its recommendations to manufacturers in time for updated vaccines to be available for the 2025-2026 influenza season.”
February 24, 2025 | FDA Extends the Effective Date for the “Healthy” Final Rule
The FDA is postponing the effective date for the final rule, entitled “Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy’” until April 28, 2025. The final rule was published with an effective date of February 25, 2025. The FDA is postponing the effective date in accordance with the January 20, 2025, memorandum from the President, entitled “Regulatory Freeze Pending Review” with respect to reviewing any questions of fact, law, and policy applicable to rules that have been published in the Federal Register but have not taken effect.
February 17, 2025 | Jim Jones, Deputy Commissioner for Human Foods at the FDA, resigned from his position.
Jim Jones, deputy commissioner for human foods at the U.S. Food and Drug Administration (FDA), resigned from his position Feb. 17, citing the Trump administration’s layoffs of 89 staffers in the agency’s food division in his reasoning for resignation.
February 16, 2025 | FDA Begins Layoffs as Trump Administration Moves to Reduce Federal Workforce
Probational employees at the Food and Drug Administration have begun recieving letters of termination shortly following the president’s February 11th Executive Order, seeking to reduce the federal workforce.
February 13, 2025 |Robert F. Kennedy, Jr. Sworn in as 26th Secretary at HHS, Overseeing FDA
Robert F. Kennedy, Jr. today was sworn in as the 26th Secretary of the U.S. Department of Health and Human Services (HHS), responsible for overseeing the US FDA.
February 5, 2025 |FDA / HHS Release Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs
This guidance has been prepared jointly by the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). To enhance human subject protection and reduce regulatory burden, OHRP and FDA have been actively working to harmonize the Agencies’ regulatory requirements and guidance for human subject research. This guidance document was developed as a part of these efforts.
January 24, 2025 | Dr. Sara Brenner Appointed Acting FDA Commissioner
Dr. Sara Brenner was appointed Acting Commissioner of Food and Drugs at the FDA, succeeding Dr. Robert Califf. Brenner, who worked in the FDA’s Center for Devices and Radiological Health, will take the helm of the agency until a new commissioner is confirmed.
January 20, 2025 | Dr. Robert Califf Ends Second Term as FDA Commissioner
Dr. Robert Califf concludes his second term as FDA commissioner, stating “I feel good about the shape that we’re leaving the agency in,”.
January 20, 2025 | President Trump Issues Regulatory Freeze
On January 20, 2025, President Trump released an executive memo, “Regulatory Freeze Pending Review,”. The memo directs all executive agencies to not propose or issue any rule without the approval of an appointed agency head or the President. The memo also directs agencies to withdraw any rules that have been submitted to the Office of the Federal Register but have not been published. In addition, the memo directs agencies to consider postponing the effective dates of rules that have been finalized and published in the Federal Register, but have not become effective yet.
January 18, 2025 | Jacqueline Corrigan-Curay Named Acting Director of CDER
Jacqueline Corrigan-Curay J.D., M.D., has been named acting director of the FDA’s Center for Drug Evaluation and Research following former Director Dr. Patrizia Cavazzoni’s retirement announcement last week.
January 10, 2025 | Dr. Patrizia Cavazzoni Announces Retirement as Director of CDER
Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER), announced her retirement Friday (Jan. 10), capping off over a decade at the agency, including more than four years as CDER’s top official. CDER Principal Deputy Director Jacqueline Corrigan-Curay is set to serve as acting director following Dr. Cavazzoni’s retirement on January 18.
