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GUIDANCE DOCUMENT

Role of HIV Drug Resistance Testing in Antiretroviral Drug Development October 2007

Final
Docket Number:
FDA-2004-D-0242
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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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Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2004-D-0242.