III. POLICY The NDA/ANDA/AADA holder should follow the procedure outlined in Form FDA 2252 when filing an Annual Report. Annual Reports should be filed for all approved NDAs, ANDAs and AADAs (including those for bulk antibiotic drugs), regardless of their activity status. For NDAs filed with...
APPENDIX B: EXAMPLES OF CHANGES TO BE DOCUMENTED IN AN ANNUAL REPORT FROM FDA’S SUPAC-IR, ...
clinical trials described in Section 506B of the FDCA. If an applicant chooses to use the form, the applicant should submit it instead of adding a company-derived status update document in the eCTD. Additionally, if opting to submit Form FDA 3989, applicants must complete Form FDA 2252 as ...