Post-Marketing Commitment
A study that a drug sponsor agrees to conduct after approval, distinct from post-marketing requirements in that commitments are agreed upon rather than mandated. The FDA publicly tracks the status of all post-marketing commitments and requirements.
Technical Context
PMCs are studies that a sponsor agrees to conduct but that are not legally mandated under the same authorities as PMRs. PMCs arise from: agreements made during the approval process (discussions at advisory committee meetings or in approval letters), sponsor-initiated commitments to address remaining questions, and international harmonisation requirements. While PMCs carry less formal enforcement authority than PMRs, failure to fulfil them can affect the sponsor's credibility with regulators and may be considered in future regulatory interactions. Both PMRs and PMCs are publicly listed on the FDA website with status updates (pending, ongoing, submitted, fulfilled, released, or unfulfilled). The distinction between PMR and PMC reflects the legal basis for the requirement rather than the scientific importance.