- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2014-D-1953.