fda的dmf是什么意思？
编辑：自学文库
时间：2024年03月09日
DMF refers to Drug Master File, which is a submission to the U.S. Food and Drug Administration (FDA) by a drug manufacturer containing detailed information about the manufacturing processes, components, and facilities used in the production of a pharmaceutical product. The purpose of a DMF is to provide confidential information to the FDA about the drug's chemistry, manufacturing, and controls without disclosing it to the public. This allows the FDA to review the information and evaluate the safety, efficacy, and quality of the drug without disclosing proprietary information. A DMF is often submitted by the drug manufacturer to support the approval of a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). It serves as a reference document for the FDA during the evaluation process, ensuring compliance with regulatory standards and promoting public health and safety.