Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for C
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 guidan
| Agency | Health and Human Services Department, Food and Drug Administration |
|---|---|
| Document type | Notice |
| Published | 2026-03-03 |
| 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, Manu |
| Document number | 2026-04196 |
| Official record | https://www.federalregister.gov/documents/2026/03/03/2026-04196/recommendations-on-scale-up-and-postapproval-changes-guidances-for-industry-request-for-comments |