Post-Marketing Requirement
A study or clinical trial that the FDA requires a drug sponsor to conduct after approval to further assess safety, efficacy, or optimal use. Failure to comply with post-marketing requirements can result in regulatory action. They are common for drugs receiving accelerated approval.
Technical Context
PMRs are studies or clinical trials that the FDA requires a sponsor to conduct after approval, mandated under specific legal authorities (FDAAA 2007, Section 505(o)(3) for safety studies; Accelerated Approval provisions for confirmatory trials; Paediatric Research Equity Act for paediatric studies). Non-compliance can result in: warning letters, civil monetary penalties, misbranding charges, and withdrawal of approval (for accelerated approval products). PMRs are tracked on the FDA's PMR/PMC database with defined milestones (submission of protocol, study initiation, interim reports, final report). For GLP-1 RAs, PMRs have included: medullary thyroid carcinoma registry studies (long-term C-cell tumour surveillance), paediatric efficacy/safety studies, and cardiovascular outcomes trials.