Zdrowie i gospodarka · 23/07/2026

FDA Publishes Strategy Document to Enhance Chemistry, Manufacturing, and Controls Readiness for Accelerated Clinical Development

The FDA has released a strategy document outlining its plans to improve chemistry, manufacturing, and controls (CMC) readiness for products with accelerated clinical development timelines, in line with its commitment under the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures Fiscal Years 2023-2027.