The Priority Review

Regulation

FDA actions, week of November 2, 2026: 1 proposed rule, 1 announcement

The FDA published 2 actions so far in the week of November 2 to 8, 2026: 1 proposed rule in the Federal Register and 1 press announcement.

Compiled by code from the stream briefs and public records linked below; no model wrote this page. How we use automation

Each line below links the stream brief and the agency's own record, grouped by the type of record.

This page updates as the week's records arrive. The week ends on Sunday, November 8, 2026.

Proposed rules

Other announcements

  • FDA issues final guidance for cell and gene therapy manufacturers. The FDA today issued final guidance for cellular and gene therapy (CGT) manufacturers, replacing its 2011 potency testing guidance and recommending a Potency Assurance Strategy for products treating serious or life-threatening conditions. The FDA will host a webinar on December 10, 2026 to help stakeholders understand and implement the guidance. Source: FDA press announcement, November 2, 2026.

How this page is made

Code builds this page from the stream briefs linked above, grouped by the type of record. No model writes this page. Software wrote each brief from one primary record, and code checked every number and name in it against that record. The source link opens the record itself.