Zdrowie i gospodarka · 01/09/1999

Draft Guidance for Industry on Clinical Considerations for Accelerated and Traditional Approval of Antiretroviral Drugs Using Plasma HIV RNA Measurements; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Clinical Considerations for Accelerated and Traditional Approval of Antiretroviral Drugs Using Plasma HIV RNA Measurements.'' The draft guidance is intended to assist pharmaceutical sponsors in the development of antiretroviral drugs and to serve as a focus for continued discussion among the agency, the public, industry, and scientific communities regarding the use of plasma human immunodeficiency virus (HIV) ribonucleic acid (RNA) measurements in phase 3 clinical studies of antiretroviral drugs.