Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting (PSCP)

On November 2, 2022, the committee will discuss the Center for Drug Evaluation and Research (CDER) Quality Management Maturity (QMM) program. QMM is the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement. CDER has proposed the development of a rating system that will help incentivize drug manufacturers to adopt more mature quality management practices at their facilities. The committee will consider the impact that a QMM program would have on the pharmaceutical industry, drug shortages, and supply chain resiliency. FDA will seek input to determine if experts from academia and industry support the development of a CDER QMM program to incentivize investments in mature quality management practices.
Meeting Information and Materials:
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