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Zdrowie i gospodarka · 5.06.2013

Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment." The purpose of this guidance is to assist sponsors in all phases of development of antiretroviral drugs for the treatment of HIV. This draft guidance revises the guidance for industry entitled "Antiretroviral Drugs Using Plasma HIV RNA Measurements--Clinical Considerations for Accelerated and Traditional Approval" issued in October 2002.

Source: Federal Register — Food and Drug AdministrationOpen original release →