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FDA Extends Deadline Requiring Drug Master Files in Electronic Format

The U.S. Food Drug and Administration (FDA) announced on April 7, 2017, that the requirement to submit all new Drug Master File (DMF) applications in electronic eCTD format will be extended by one year, from May 5, 2017 to May 5, 2018. The new deadline was included in an update to the guidance, Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.

In the updated guidance, FDA states that the deadline extension is in response to industry comments and internal review. Explaining, the Agency wrote, "Among other factors, FDA recognizes that there have been challenges with submission of master files in eCTD format, and eCTD uptake data for master files in particular indicated that adhering to the May 5, 2017 date could have led to high rejection rates of master files and thus slower FDA review processes, and, therefore, potential unnecessary delay in the review of some drug applications."

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...