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FEDERAL REGISTER · NOTICESeptember 15, 2023NOTICE — NO LEGAL EFFECT

Quality Management Maturity Program for Drug Manufacturing Establishments; Establishment of a Public Docket; Request for Comments

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSNOTICE — NO LEGAL EFFECT
EFFECTIVE—
COMMENTS CLOSEDec 14, 2023 · closed
APPLIES TO · SPEQ TAGDrugBiologicsDevice
Document type
Notice
Agency
Health and Human Services Department
Published
September 15, 2023
Comments close
December 14, 2023
Document number
2023-20015
Docket
FDA-2023-N-3721
ABSTRACT

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).

Abstract as published in the Federal Register.

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