Zdrowie i gospodarka · 01/11/2002

FDA Releases Guidance on Accelerated Approval of HIV Antiretroviral Drugs Using Plasma HIV RNA Measurements

The Food and Drug Administration (FDA) has released a guidance document for the pharmaceutical industry, titled 'Antiretroviral Drugs Using Plasma HIV RNA Measurements--Clinical Considerations for Accelerated and Traditional Approval,' which provides clinical considerations for the approval of antiretroviral drugs for HIV treatment. The guidance aims to assist sponsors in the development of these drugs.