In the Federal Register of March 3, 2026, the FDA published a request for information and comments on the Agency’s series of guidances for industry on Scale-Up and Post-Approval Changes (SUPAC) for specific dosage forms. Based on the requests received from interested parties, the FDA is reopening the comment period and extending it for an additional 30 days.
There has been considerable interest in the modernization of the SUPAC guidance documents to provide additional regulatory clarity and, in some cases, additional regulatory relief. In our blog post on this topic, dated March 2, 2026 (here), we described the potential benefits of reevaluating the SUPAC documents and the Agency’s appetite for readdressing the various SUPAC guidances to more accurately reflect changes in the ICH guidances as well as advances in knowledge since their initial issuance. The Federal Register Notice announcing the extension of the comment period can be found here.
