Regulatory Compliance, Industry Standards
17 Jan 2025
regulatory compliance, fda, pharmaceutical industry, drug master file, abbreviated new drug applications
💊FDA Notice on Type V Drug Master Files for ANDA Support
The Food and Drug Administration (FDA or Agency), Center for Drug Evaluation and Research (CDER), Office of Generic Drugs is establishing a public docket entitled "Use of a Type V Drug Master File (DMF) for Model Master File (MMF) Submissions to Support Abbreviated New Drug Applications (ANDAs)." The purpose of this docket to solicit input from interested parties on this topic.
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