Vaginal Microbicides:Development for the Prevention of HIV Infection PDF November 2014
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance provides recommendations for the development of vaginal microbicides regulated within the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) for the prevention of human immunodeficiency virus (HIV) infection. Specifically, this guidance addresses the FDA’s current thinking regarding the overall development program and clinical trial designs to support the development of vaginal microbicide drug products.
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-2012-D-1120.