FDA draft guidance on using HIV drug resistance tests for drug development.(Regulatory Update)

In the Nov. 29, 2004, Federal Register, FDA announced the availability of a draft guidance for industry titled, Role of HIV Drug Resistance Testing in Antiretroviral Drug Development. This draft guidance is intended to assist sponsors in the clinical development of drugs for the treatment of human immunodeficiency virus (HIV) infection. Specifically, the draft guidance addresses the role of HIV resistance testing during antiretroviral drug development and postmarketing. The draft guidance also is intended to serve as a focus for continued discussions among FDA, pharmaceutical sponsors, the academic community, and the public. The draft guidance is based on an FDA Antiviral Drug …