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Pediatric HIV Infection: Drug Development for Treatment; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Pediatric HIV Infection: Drug Development for Treatme...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Pediatric HIV Infection: Drug Development for Treatment.'' This guidance provides general recommendations on the development of drug products for the treatment of human immunodeficiency virus (HIV) infection in pediatric patients (birth to younger than 17 years of age).

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83 FR 22270

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“Pediatric HIV Infection: Drug Development for Treatment; Draft Guidance for Industry; Availability,” thefederalregister.org (May 14, 2018), https://thefederalregister.org/documents/2018-10187/pediatric-hiv-infection-drug-development-for-treatment-draft-guidance-for-industry-availability.