Use of a Type V Drug Master File for Model Master File Submissions To Support Abbreviated New Drug Applications; Establishment of a Public Docket; Request for Comments
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.
Abstract as published in the Federal Register.
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