Public Meeting on PDUFA Reauthorization Scheduled

Key changes

Proposals for PDUFA VIII funding levels and performance goals; recommendations for enhancing safety reporting infrastructure, the Sentinel System, and the review of postmarketing safety data; opportunities for stakeholder input on pharmacovigilance resource allocation.

PV impact

PDUFA reauthorization is the primary legislative mechanism for setting pharmacovigilance policy and funding in the US. The proposed initiatives directly impact the scale and speed of safety signal detection, the modernization of adverse event reporting systems, and the overall capacity of the FDA to conduct post-approval safety monitoring.

Exact policy details

Current PDUFA Authorization Expiration

September 2027

Applies to: PDUFA VII

The current legislative authority for PDUFA expires in September 2027. · p. 4 · High · Source

Public Meeting Date

September 16, 2026

Applies to: Public Meeting for PDUFA Reauthorization

The hybrid public meeting will be held on September 16, 2026. · p. 5 · High · Source

Comment Submission Deadline

October 16, 2026

Applies to: Deadline for public written comments

Submit either electronic or written comments on this public meeting by October 16, 2026. · p. 5 · High · Source

Public Comment Review Period

30 days

Applies to: Public engagement on recommendations

…provide for a period of 30 days for the public to provide written comments... · p. 4 · High · Source

Extracted documents

• Public Inspection: Hearings, Meetings, Proceedings, etc.: Reauthorization of the Prescription Drug User Fee Acthtmlhtml · high · 1 page
• download the unpublishedpdfpdf_text · high · 18 pages
• No FEAR Act Noticehtmlhtml · high · 1 page
• About the Federal Registerhtmlhtml · high · 1 page