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# FDA Issues HIV Drug Development Guidances
- URL: https://www.fdaweb.com/fda-issues-hiv-drug-development-guidances/
- Published: 2019-03-19T12:00:00.000Z
- Updated: 2026-09-15T01:13:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143644

FDA has issued two final guidances to help product sponsors understand agency thinking about preventive treatments for HIV as well as treatments for pediatric patients with HIV. The first [guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM610623.pdf?ref=fdaweb.com), *Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis*, gives sponsors nonclinical and clinical recommendations specific to developing systemic drug products, with a focus on long-acting systemic drug products, including small molecules and monoclonal antibodies, regulated within CDER for preventing sexually acquired HIV-1 infection. The document addresses agency thinking on the overall development program and clinical trial designs to support development of systemic drug products for preventing HIV-1 infection. It does not address development of vaginal microbicide drug products.

The second [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM607416.pdf?ref=fdaweb.com), *Pediatric HIV Infection: Drug Product Development for Treatment*, provides general recommendations on developing antiretroviral drug products for treating HIV infection in pediatric patients. It is to help sponsors understand when it is appropriate to initiate pediatric formulation development and begin pediatric studies.