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Hearing on "FDA User Fee Reauthorization: Ensuring Safe and Effective Drugs and Biologics"

Date: 
Thursday, February 3, 2022 - 10:00am
Location: 
Hybrid Hearing in the John D. Dingell Room, 2123 of the Rayburn House Office Building, and Cisco Webex

The Subcommittee on Health of the Committee on Energy and Commerce held a hybrid hearing that included both in-person and remote attendance on Thursday, February 3, 2022, at 10:00 a.m. This hearing took place in the John D. Dingell Room, 2123 of the Rayburn House Office Buidling, as well as remotely using Cisco Webex online video conferencing. The hearing is entitled, "FDA User Fee Reauthorization: Ensuring Safe and Effective Drugs and Biologics."

 

Key Documents

Memorandum from Chairman Pallone to the Subcommittee on Health 

Opening Statement from Chairman Pallone as prepared for delivery

Opening Statement from Subcommittee Chairwoman Eshoo as prepared for delivery

 

Livestream

 

Legislation

H.R.____, the "Biosimilar User Fee Amendments of 2022"

H.R.____, the "Generic Drug User Fee Amendments of 2022"

H.R.____, the "Prescription Drug User Fee Amendments of 2022" 

 

Witnesses

Panel I

Patrizia Cavazzoni, M.D.
Director, Center for Drug Evaluation and Research
U.S. Food and Drug Administration

 

Peter Marks, M.D., Ph.D.
Director, Center for Biologics Evaluation and Research
U.S. Food and Drug Administration

 

Testimony of the U.S. Food and Drug Administration

 

Panel II

Cartier Esham, Ph.D.
Chief Scientific Officer
Executive Vice President, Emerging Companies
Biotechnology Innovation Organization

Testimony

 

David Gaugh
Senior Vice President, Sciences and Regulatory Affairs
Association for Accessible Medicines

Testimony

 

Reshma Ramachandran, M.D.
Physician-Fellow, Yale National Clinician Scholars Program
Chair, Doctors for America FDA Task Force

Testimony

 

Juliana M. Reed
Executive Director
Biosimilars Forum

Testimony

 

Lucy Vereshchagina, Ph.D.
Vice President, Science and Regulatory Advocacy
Pharmaceutical Research and Manufacturers of America

Testimony

 

Issues: