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.
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.
