07-22-2019 FDA is announcing the withdrawal of the draft guidance for industry Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information, issued in December 2016. The draft guidance, when finalized, was intended to implement section 745A of the Federal Food, Drug, and Cosmetic Act, which requires that drug applications be submitted in an electronic format. It would have also streamlined the review of manufacturing establishments involved in preparing a drug or biological product by consolidating information in one location. After considering the public comments received, FDA has decided to withdraw the draft guidance and reevaluate its approach to submission of manufacturing establishment information in drug applications.
FDA will communicate publicly in the event that a new draft guidance on submission of manufacturing establishment information is issued.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.