Navigating FDA's clinical trial expectations after approval
Today, we're diving into the FDA's Fiscal Year 2022 report on postmarketing requirements (PMRs) and postmarketing commitments (PMCs). PMRs are mandatory studies required by the FDA after a drug's approval, focusing on real-world data for long-term safety and effectiveness. Think of them as an extension of the initial research phase, but in a real-world setting. PMCs, while not legally mandated, are additional studies agreed upon by the drug developer, providing valuable insights.Both PMR...