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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."

© 2019 Keller and Heckman LLP


About this Author

Joan Sylvain Baughan, Food and drug law, Keller and Heckman, Law Firm

Joan Sylvain Baughan practices food and drug law, focusing on U.S. Food and Drug Administration (FDA) and comparable international regulation of food contact materials, drugs, cosmetics, and medical devices. 

In addition to practicing in the firm's Washington office, Ms. Baughan spent three years counseling foreign and domestic clients from the firm's Brussels, Belgium office. While there, she developed an expertise in the regulation of food packaging materials and medicinal products under European Union and Member State legislation.