Zdrowie i gospodarka · 19/11/2014

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

The Food and Drug Administration (FDA) is announcing the availability of a 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, defined as vaginal drug products that prevent human immunodeficiency virus (HIV) acquisition. The guidance outlines the types of nonclinical studies and clinical trials recommended throughout the drug development process to support approval of vaginal microbicides. This guidance finalizes the draft guidance issued on November 23, 2012.