Testimony
Event Title
FDA User Fee Agreements: Advancing Medical Product Regulation and Innovation for the Benefit of Patients, FDA Center Directors
April 26, 2022
Event Title
FDA User Fee Agreements: Advancing Medical Product Regulation and Innovation for the Benefit of Patients, FDA Center Directors
- Testimony of
-
Patrizia Cavazzoni, M.D.
Director - Center for Drug Evaluation and Research
Peter Marks, M.D., PhD.
Director - Center for Biologics Evaluation and Research (CBER)
Jeffrey E. Shuren, MD, JD
Director - CDRH Offices: Office of the Center Director
INTRODUCTION
Chair Murray, Ranking Member Burr, and Members of the Committee, thank you for the opportunity to testify today on the reauthorizations of the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA), and the Biosimilar User Fee Act (BsUFA), Medical Device User Fee Amendments (MDUFA) and the Food and Drug Administration’s (FDA, the Agency, we or our) efforts to deliver timely access to safe and effective medications and medical devices for all Americans. We appreciate the efforts of Congress and this Committee in particular in successfully reauthorizing these programs in previous cycles, and look forward to continuing our partnership this year.