PDUFA Archives

Patient, Consumer, and Public Health Coalition Letter to Senate HELP and Energy and Commerce Committee Regarding User Fee Reauthorization Legislation

September 22, 2022: It is critically important that House and Senate committees work together to consolidate differences between the Food and Drug Amendments Act (H.R. 7667), which passed the House of Representatives on June 8, and the Food and Drug Administration Safety and Landmark Advancements Act (S. 4348), which passed the Senate Health, Education, Labor, and Pensions (HELP) Committee on June 15.

Public Comment PDUFA VII Commitment Letter (Docket #FDA-2021-N-0891) From the National Center for Health Research

October 28, 2021: NCHR comments on the proposed PDUFA VII Commitment Letter from the FDA.

Testimony of Dr. Diana Zuckerman, NCHR, at the FDA PDUFA Meeting, September 28, 2021

September 28, 2021: After reviewing FDA’s PDUFA VII plans, I have concerns about the performance goals and policies that the FDA has negotiated with industry behind closed doors.