CDER Launches 2 Quality Management Pilot Programs For APIs and FDFs

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2026-01-12 11:47:12 -

The Center for Drug Evaluation and Research (CDER) launched two (2) quality management pilot programs for Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs). The purpose of the pilot programs was to gain insight from the third-party assessments of the manufacturer’s quality management system (QMS) and enhance the future development of the FDA Quality Management...

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