FDA seeks comments on pediatric HIV product development


The U.S. Food and Drug Administration announced a draft guidance for industry entitled “Pediatric HIV Infection: Drug Development for Treatment.” This draft guidance provides general recommendations for developing products to treat HIV infections in pediatric patients (from birth to younger than 17 years of age).

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This guidance document is being distributed for comment purposes only, according to the FDA. Comments and suggestions should be submitted by July 13. Electronic comments should be submitted to www.regulations.gov, while written comments should be submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number (Docket No. FDA-2018-D-1638) as described in the May 14 Federal Register announcement.

According to the FDA announcement, the draft includes recommendations on when sponsors should initiate pediatric formulation development and when to begin pediatric studies to evaluate antiretroviral drug products for the treatment of HIV infection.

SOURCE: Federal Register May 14. Pediatric HIV Infection: Drug Development for Treatment; Draft Guidance for Industry; Availability.

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