The Priority Review

The stream · Daily digest

The stream: Saturday, October 10, 2026

2 briefs from the Federal Register, grouped by desk. Each is two sentences from one primary source, linked to it.

Machine-summarized from primary sources; not independently reported. How we use automation

Regulation · 2

  1. FDA finalizes guidance on post-approval manufacturing changes to biosimilars

    FDA announced the availability of a final guidance titled "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers." The guidance supersedes the draft issued July 23 2024 and withdraws Q&A I.20 from the Q&A biosimilar development guidance.

    Source: Federal Register notice, October 13, 2026

  2. FDA final rule permits salt substitutes in standardized foods

    The rule, effective December 14, 2026, amends FDA's standards of identity to permit the use of salt substitutes in standardized foods. The change is intended to reduce sodium content in these foods.

    Source: Federal Register rule, October 13, 2026