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

Issue Date: December 18, 2014
Issued by: Center for Drug Evaluation and Research
Topic(s): Electronic Submissions,
Status: Final

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

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.

Download the Guidance Document