federal_register: 2012-28430

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2012-28430 Draft Guidance for Industry on Vaginal Microbicides: Development for the Prevention of Human Immunodeficiency Virus Infection; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Vaginal Microbicides: Development for the Prevention of HIV Infection."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. 2012-11-23 2012 11 https://www.federalregister.gov/documents/2012/11/23/2012-28430/draft-guidance-for-industry-on-vaginal-microbicides-development-for-the-prevention-of-human https://www.govinfo.gov/content/pkg/FR-2012-11-23/pdf/2012-28430.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Vaginal Microbicides: Development for the Prevention of HIV Infection."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...

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