Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments

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.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.