Health and Human Services Department Docket FDA-2023-N-0001 Notice

2023-20903: Advancing the Development of Pediatric Therapeutics on Drug Dosing in Pediatric Patients With Renal Impairment; Public Workshop

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Summary

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Advancing the Development of Pediatric Therapeutics (ADEPT 8) on Drug Dosing in Pediatric Patients With Renal Impairment." The purpose of the public workshop is to discuss the current landscape of drug dosing in pediatric patients with renal impairment, understand the gaps in knowledge, and consider innovative approaches to improve the current paradigm for dosing in pediatric patients with renal impairment.

The agency’s own summary, as published.

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