Draft Guidance for Industry on the Role of Human Immunodeficiency Virus Drug Resistance Testing in Antiretroviral Drug Development; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Role of HIV Drug Resistance Testing in Antiretroviral Drug Development." This draft guidance is intended to assist sponsors in the clinical development of drugs for the treatment of human immunodeficiency virus (HIV) infection. Specifically, the draft guidance addresses the role of HIV resistance testing during antiretroviral drug development and postmarketing. The draft guidance is also intended to serve as a focus for continued discussions among the Division of Antiviral Drug Product (DAVDP) in FDA's Center for Drug Evaluation and Research, pharmaceutical sponsors, the academic community, and the public.