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Postmarketing Commitments (PMCs)

Meaning

Postmarketing Commitments (PMCs) are formal studies or clinical trials that a pharmaceutical sponsor agrees to conduct after a drug has received regulatory approval and is commercially available for public use. These commitments are often requested or mandated by regulatory agencies, such as the FDA, to gather additional, specialized information about a drug’s long-term safety, efficacy in specific patient subpopulations, or optimal dosing that was not fully addressed during the initial pre-approval process. PMCs are a crucial regulatory tool that ensures ongoing surveillance and continuous refinement of a medication’s known risk-benefit profile, particularly vital for chronic hormonal therapies.