2026-04196: Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments
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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.
The agency’s own summary, as published.
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