The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis.'' This draft guidance provides nonclinical and clinical recommendations specific to the development of systemic drug products, with a focus on long-acting systemic drug products, regulated within the Center for Drug Evaluation and Research (CDER) at FDA for the prevention of sexually acquired human immunodeficiency virus-1 (HIV-1) infection.
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Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing ...
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83 FR 27782
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“Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis; Draft Guidance for Industry; Availability,” thefederalregister.org (June 14, 2018), https://thefederalregister.org/documents/2018-12761/human-immunodeficiency-virus-1-infection-developing-systemic-drug-products-for-pre-exposure-prophylaxis-draft-guidance-f.