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

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2026-N-0809] AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for information and comments. SUMMARY: 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 guidance…