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Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments
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Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA, the Agency, or we) is announcing the opening of a public docket to solicit information and comments on the Agency's series of guidances for industry on scale-up and postapproval changes (SUPAC) for specific dosage forms. Specifically, we are seeking comment on the following guidances for industry: "Immediate Release Solid Oral Dosage Forms Scale-Up and Postapproval 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 Postapproval 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 Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation" (SUPAC-MR); and "SUPAC: Manufacturing Equipment Addendum" (SUPAC-MEA). The Agency is seeking public information and comment on the continued utility of and suggestions for potential revisions to the recommendations in these guidances.
- Document type
- Notice
- Federal Register document number
- 2026-04196
- Published
- Mar 3, 2026
- Action
- Notice; request for information and comments.
- Docket
- FDA-2026-N-0809
- Comments posted on Regulations.gov (at last check)
- 53
- DATES section (from the document)
- Submit either electronic or written comments on the notice by June 1, 2026 to ensure that the Agency considers your comment on these guidance documents before it begins work on any revisions.
- Topics (auto-tagged)
- CMC (chemistry, manufacturing & controls)
Source: Federal Register API, document 2026-04196. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.