> ## Content Index
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# Guide on Pre-Exposure HIV Drug Development
- URL: https://www.fdaweb.com/guide-on-pre-exposure-hiv-drug-development/
- Published: 2019-03-20T12:00:00.000Z
- Updated: 2026-09-15T01:14:08.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143655

*Federal Register* notice: FDA has made available a final guidance entitled “Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis.” The document provides sponsors with 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). To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-03-20/pdf/2019-05231.pdf?ref=fdaweb.com).