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FDA Withdraws Guidance on Electronically Submitting Manufacturing Establishment Info

Posted 29 July 2019 | By Zachary Brennan 

FDA Withdraws Guidance on Electronically Submitting Manufacturing Establishment Info

The US Food and Drug Administration (FDA) last week withdrew draft guidance published in December 2016 on submitting manufacturing establishment information electronically.

“After considering the public comments received, FDA has decided to withdraw the draft guidance and reevaluate its approach to submission of manufacturing establishment information in drug applications,” the agency said.

Many of the comments on the draft guidance, which was intended to implement section 745A of the Federal Food, Drug, and Cosmetic Act, noted that FDA’s approach was not aligned with international work on electronically transmitting registration information.

Industry group PhRMA said that the draft, as written, “will require sponsors to maintain multiple dossiers, which is in direct conflict with the move towards global standards and harmonization of electronic submissions, and would have a significant, and unacceptable, impact on sponsors.”

FDA said it will publicly announce if any new draft guidance on the submission of manufacturing establishment information is issued. ​

Providing Regulatory Submissions in Electronic Format--Submission of Manufacturing Establishment Information Guidance for Industry

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Tags: eCTD, FDA, MEI, PhRMA

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