- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological HealthCenter for Drug Evaluation and Research
This guidance is intended to provide information to applicants and manufacturers regarding compliance with the requirements in part 4 (21 CFR part 4) for ophthalmic drugs packaged with eye cups, eye droppers, or other dispensers. This guidance applies to products with pending applications, approved products, and products marketed pursuant to section 505G of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h) without an approved application under section 505 of the FD&C Act (21 U.S.C. 355) (commonly referred to as over-the-counter (OTC) monograph drugs).
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-2022-D-0192.