§356b Reports of postmarketing studies

Summary

Drug makers who agreed with the Secretary to do postmarketing studies must send progress reports. For most drugs, the first report is due within 1 year after approval and then once a year until the study is finished or stopped. The reports must follow the form the Secretary requires. For drugs approved under accelerated approval, the company must report within 180 days after approval and then at least every 180 days until the study is done. Those reports must include things like enrollment progress and milestones, and the FDA must post that information on its website in a searchable way. Agreements made before November 21, 1997 follow the 1‑year rule, and their first report is due within 6 months after the Secretary issues the rules. Information in these reports is public enough to name the sponsor and show the study’s status or why it was not done. The Secretary must publish an annual status report in the Federal Register about agreed studies and studies with submitted reports. If a sponsor misses a deadline, the FDA must post that the study was not completed and say if the reasons were not satisfactory. For certain study types listed in the law or FDA rules (section 356(c)(2)(A) or 21 CFR 314.510 or 601.41 as they existed the day before this took effect), the Secretary may require a sponsor who failed for unsatisfactory reasons to notify doctors about the unfinished study and any remaining questions about benefit or safety. This does not change what studies are required or stop the Secretary from changing the rules.