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DRUG M HOLISM AND DISPOSITION The Biological Fate 01ChemIcals Editor: Raymond DRUG F. Novak, METABOLISM in vitro and results information exogenous The and letters a high standard metabolism, State
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Drug m - dmd stands for Drug Master File Biological Product Drug Substance and is a submission to FDA containing confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
Any person or entity who is involved in the manufacturing, processing, packaging, or storing of human drugs and wants to maintain confidentiality of proprietary information is required to file drug m - dmd.
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The purpose of drug m - dmd is to allow a person or entity to provide confidential information to FDA regarding the facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs without disclosing it to the public.
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