FDA Annual Report
An annual report is required for important FDA filings. Your FDA annual reports gives the FDA a high level view of your product and process, but some companies (particularly virtual/small companies and investigator-sponsors) see the annual as an unnecessary burden.
No matter your view, Annual Reports are absolutely required by law and failing to submit one can be grounds for enforcement action (for an example, see our article on Warning Letter).
The annual report process should be used as an opportunity to reflect upon your program, especially the safety profile in the clinical trials to date, and ensure that everything that has been done (or is planned) will keep you moving towards your goal.
The annual report may include new safety, efficacy, labeling information; preclinical and clinical investigation summaries; Chemistry Manufacturing and Controls (CMC) updates; nonclinical laboratory studies; and completed unpublished clinical trials.
For more information, select the type of filing below: