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GUIDANCE DOCUMENT

Pediatric HIV Infection: Drug Development for Treatment March 2019

Final
Docket Number:
FDA-2018-D-1638
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The purpose of this guidance is to provide general recommendations on the development of antiretroviral (ARV) drug products2 for the treatment of human immunodeficiency virus (HIV) infection in pediatric (birth to younger than 18 years of age) patients. This guidance is intended to help sponsors understand when it is appropriate to initiate pediatric formulation development and to begin pediatric studies.


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All written comments should be identified with this document's docket number: FDA-2018-D-1638.