2023-20015: Quality Management Maturity Program for Drug Manufacturing Establishments; Establishment of a Public Docket; Request for Comments
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The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to solicit comments that will assist the Agency in developing a Quality Management Maturity (QMM) program for establishments manufacturing human drugs, including biological products, regulated by the Center for Drug Evaluation and Research (CDER).
The agency’s own summary, as published.
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