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GUIDANCE DOCUMENT

Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act December 2014

Final

Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act

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

Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by section 1136 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144), requires that submissions under section 505(b), (i), or (j) of the FD&C Act2 and submissions under section 351(a) or (k) of the Public Health Service Act (PHS Act)3 be submitted in electronic format specified by the Food and Drug Administration (FDA or the Agency) beginning no earlier than 24 months after FDA issues a final guidance specifying an electronic submission format.


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.