FDA recently released a draft guidance document titled, Request for Quality Metrics, designed to explain how the Center for Drug Evaluation and Research ("CDER") and the Center for Biologics Evaluation and Research ("CBER") collect and use quality metrics to support improvement and innovation in the pharmaceutical manufacturing industry. In conjunction with releasing and soliciting comments on the draft guidance document, FDA announced it will hold a public meeting on the topic on August 24, 2015. The draft guidance and meeting reflect FDA's efforts in the development and planned implementation of a quality metrics program launched under section 704 of the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Safety and Innovation Act to enhance the agency's record-requesting authority in connection with drug establishment inspections.
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