FDA SUPAC guidance updates?
- Date
- March 3, 2026
- Category
US Regulations
- Description
On 3 March 2026 FDA published a request for comments, see Federal Register :: Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments, on their many Scale-Up and Post-approval Changes (SUPAC) Guidance for Industry documents, many of which date back to the 1990’s. FDA say that they recognise that more recent guidance, including ICH guidance, supersedes or conflicts with the older SUPAC guidelines. Comments can be submitted until 1 June 2026.
Specifically, they FDA seeking comment on the following guidance for industry:
- “Immediate Release Solid Oral Dosage Forms Scale-Up and Post-approval Changes: Chemistry, Manufacturing, and Controls,
- In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation” (SUPAC-IR);
- “SUPAC-IR Questions and Answers about SUPAC-IR Guidance” (SUPAC-IR Q&A);
- “Nonsterile Semisolid Dosage Forms Scale-Up and Post-approval Changes: Chemistry, Manufacturing, and Controls;
- In Vitro Release Testing and In Vivo Bioequivalence Documentation” (SUPAC-SS);
- “SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Post-approval Changes: Chemistry, Manufacturing, and Controls;
- In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation” (SUPAC-MR); and
- “SUPAC: Manufacturing Equipment Addendum” (SUPAC-MEA).