With a new administration comes a fresh wave of changes at the FDA, 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 takes shape.
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 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 Makary mentioned outdated data as one of the reasons for the delay, stating the last study the agency has that shows a clinical benefit for this product was in 2021, and the study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.
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.
