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# Guide on Pediatric HIV Drug Development
- URL: https://www.fdaweb.com/guide-on-pediatric-hiv-drug-development/
- Published: 2019-03-20T12:00:00.000Z
- Updated: 2026-09-15T01:14:21.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143657

*Federal Register* notice: FDA has made available a final guidance entitled “Pediatric HIV Infection: Drug Product Development for Treatment.” The document provides general recommendations for developing antiretroviral drug products for treating human immunodeficiency virus infection in pediatric patients. It also addresses when to initiate pediatric formulation development and begin pediatric studies and offers approaches for enrolling subjects into pediatric studies. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-03-20/pdf/2019-05232.pdf?ref=fdaweb.com).