Issue Date: October 31, 2007
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Antimicrobial
Status: Final
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.
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