Submit Comments by
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Dockets Management
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-2022-D-2059
- Docket Number:
- FDA-2022-D-2059
- Issued by:
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Guidance Issuing Office
Center for Drug Evaluation and Research, Office of New Drugs
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Providing Over-the-Counter Monograph Submissions in Electronic Format.” This guidance provides information on providing electronic submissions to FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
