Last mentioned: Mar 7, 2026
Final Departure
Official announcement of Marks leaving the agency for the second time.
Expedited Pathway Formalized
FDA announces the formal implementation of quicker paths for gene therapy via surrogate endpoints.
Initial Friction
Reports surface of Marks considering resignation amid administrative policy shifts.
START Pilot Launch
FDA initiates a pilot program for Support for clinical Trials Advancing Rare disease Therapeutics.
CBER Reorganization
The Office of Tissues and Advanced Therapies is elevated to a 'Super Office' to handle CGT volume.
Operation Warp Speed
Plays a central role in the emergency use authorizations for COVID-19 vaccines.
Luxturna Approval
FDA approves the first gene therapy for an inherited disease, setting the initial regulatory precedent.
Appointed Director
Promoted to Director of CBER, overseeing the 'Gold Standard' of vaccine review.
Joins FDA
Dr. Peter Marks joins the FDA as Deputy Director of CBER.
Dr. Peter Marks, the long-serving head of the FDA’s vaccine division, is stepping down for the second time as the Trump administration intensifies its 'Make America Healthy Again' initiatives. His exit marks a critical turning point for the Center for Biologics Evaluation and Research and signals a potential shift in the agency's rigorous approval standards.
The U.S. Food and Drug Administration has established a streamlined regulatory pathway to expedite the development and review of gene therapies. This initiative focuses on leveraging surrogate endpoints and platform technologies to bring life-altering treatments for rare diseases to market faster.