Issue Date: September 2, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Pharmacology
Status: Draft
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage
This draft guidance assists sponsors in the design and analysis of studies that assess the influence of hepatic impairment on the pharmacokinetics and, where appropriate, the pharmacodynamics of a drug, including therapeutic biological products. When final, this guidance will represent FDA’s current thinking. FDA is also withdrawing the guidance for industry titled “Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling” (May 2003), which formerly provided FDA’s thinking relating to studies to assess the effect of hepatic impairment on the pharmacokinetics or pharmacodynamics of a drug and recommendations to include hepatic impairment information in labeling.
Download the Guidance Document
