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FEDERAL REGISTER · NOTICESeptember 26, 2023NOTICE — NO LEGAL EFFECT

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

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSNOTICE — NO LEGAL EFFECT
EFFECTIVE—
COMMENTS CLOSE—
APPLIES TO · SPEQ TAGDrug
Document type
Notice
Agency
Health and Human Services Department
Published
September 26, 2023
Document number
2023-20903
Docket
FDA-2023-N-0001
ABSTRACT

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.

Abstract as published in the Federal Register.

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The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.

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