Post-Marketing Commitments (PMCs) include study designs not mandated by the FDA.

Post-Marketing Commitments (PMCs) include study designs not mandated by the FDA.

• A. True
• B. False
• C. Not sure
• D. Occasionally

Answer: (A)

Post-Marketing Commitments are agreements to conduct studies after a product is approved that the sponsor voluntarily agrees to, rather than requirements imposed by statute. They are not mandated by the FDA, though FDA may request them to gather additional information about safety, effectiveness, or labeling after approval. The study designs under PMCs can vary and may include observational studies, registries, or even trials, depending on what the sponsor agrees to study. This is why the statement is true: PMCs involve study designs that are not mandated by the FDA. By contrast, postmarketing requirements are the legally enforceable obligations the FDA requires.

Post-Marketing Commitments are agreements to conduct studies after a product is approved that the sponsor voluntarily agrees to, rather than requirements imposed by statute. They are not mandated by the FDA, though FDA may request them to gather additional information about safety, effectiveness, or labeling after approval. The study designs under PMCs can vary and may include observational studies, registries, or even trials, depending on what the sponsor agrees to study. This is why the statement is true: PMCs involve study designs that are not mandated by the FDA. By contrast, postmarketing requirements are the legally enforceable obligations the FDA requires.