- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Medical Products and Tobacco, Center for Drug Evaluation and ResearchOffice of Medical Products and Tobacco, Center for Biologics Evaluation and Research
This guidance provides information on the implementation of new section 505(o) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 355(o)), added by section 901 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Section 505(o)(3) authorizes FDA to require certain postmarketing studies and clinical trials2 for prescription drugs approved under section 505 of the Act and biological products approved under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262).3 This guidance provides information about the requirements for postmarketing studies and clinical trials under section 505(o)(3) of the Act.
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-2009-D-0283 .