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Zdrowie i gospodarka · 23.11.2012

Draft Guidance for Industry on Vaginal Microbicides: Development for the Prevention of Human Immunodeficiency Virus Infection; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Vaginal Microbicides: Development for the Prevention of HIV Infection." The purpose of this guidance is to assist sponsors in all phases of development of vaginal microbicides for the prevention of human immunodeficiency virus (HIV) infection. The guidance outlines the types of nonclinical studies and clinical trials recommended throughout the drug development process to support approval of vaginal microbicides.

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