Role of HIV Drug Resistance Testing in Antiretroviral Drug Development
This guidance is intended to assist sponsors in the clinical development of drugs for the treatment of human immunodeficiency virus (HIV) infection. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the role of HIV resistance testing during antiretroviral drug development and marketing and serves as a focus for continued discussion among the Division of Antiviral Products (DAVP), pharmaceutical sponsors, the academic community, and the public. The goal of this guidance is to stimulate the generation of more complete resistance data and analyses for antiretroviral drug products.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.