Federal Register #2026-17961

FDA Draft Guidance on Pharmacokinetics in Patients with Impaired Hepatic Function

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has released a draft guidance for industry regarding pharmacokinetics in patients with impaired hepatic function. - Government Buyer: - Food and Drug Administration (FDA) - Department of Health and Human Services - Purpose: - Announcement of draft guidance titled "Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage" - Guidance assists sponsors in designing and analyzing studies for drugs and therapeutic biological products - Aims to inform dosage recommendations for patients with impaired hepatic function - OEMs and Vendors: - No OEMs or vendors are mentioned - Products/Services Requested: - No products or services are being procured - No part numbers or quantities listed - Unique/Notable Requirements: - FDA is withdrawing previous guidance from May 2003 - Stakeholders are invited to submit comments to shape the final guidance - Notice is informational and regulatory, not a procurement opportunity

Description

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled "Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage." This guidance assists sponsors in designing and analyzing studies that assess the influence of hepatic impairment on the pharmacokinetics and pharmacodynamics of drugs, including therapeutic biological products. The guidance aims to inform dosage recommendations for patients with impaired hepatic function. Comments on the draft guidance are invited until December 1, 2026.

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