💊FDA Notice on Type V Drug Master Files for ANDA Support
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
Summary
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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The text establishes a framework for using Type V Drug Master Files (DMFs) for Model Master File submissions to support Abbreviated New Drug Applications (ANDAs), fundamentally affecting how generic drug developers approach regulatory compliance and product submissions. This could reduce costs and time for businesses for demonstrated alternatives to in vivo studies, impacting the pharma industry's operational strategies.