ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs
Dec 2025 On December 16, 2025, the USFDA released updated guidance regarding ANDA Submissions—Amendments and Requests for Final Approval to Tentatively Approved ANDAs. This guidance is a revision (Revision 2) of the agency’s current thinking on how generic drug applicants should manage amendments to their Abbreviated New Drug Applications (ANDAs). Key Highlights of the December […]