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GUIDANCE DOCUMENT

Providing Regulatory Submissions in Electronic Format--Submission of Manufacturing Establishment Information Guidance for Industry December 2016

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Not for implementation.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
Center for Biologics Evaluation and Research

This draft guidance discusses the requirements and implementation of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) regarding valid electronic submissions of manufacturing establishment information (MEI). Twenty-four months after this draft has been finalized, MEI contained in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and amendments, supplements, or resubmissions of these application types must be submitted electronically in the format specified in this guidance. This draft guidance also applies to drug master files that are submitted for incorporation by reference into an NDA, ANDA, or BLA.


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.