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GUIDANCE DOCUMENT

Providing Regulatory Submissions in Electronic Format--Submission of Manufacturing Establishment Information Guidance for Industry July 2019

Draft

Not for implementation. Contains non-binding recommendations.

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

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

07-22-2019 FDA is announcing the withdrawal of the draft guidance for industry Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information, issued in December 2016. The draft guidance, when finalized, was intended to implement section 745A of the Federal Food, Drug, and Cosmetic Act, which requires that drug applications be submitted in an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 After considering the public comments received, FDA has decided to withdraw the draft guidance and reevaluate its approach to submission of manufacturing establishment information in drug applications.

FDA will communicate publicly in the event that a new draft guidance on submission of manufacturing establishment information is issued.​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

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:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.