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Product safetyFDAUnited StatesImports

Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage; Draft Guidance for Industry; Availability

2 September 2026

In plain English

FDA announced a draft guidance for industry on designing and analyzing pharmacokinetic studies in patients with impaired hepatic function, including therapeutic biological products, which will replace prior guidance when finalized.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
2 September 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled "Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage."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 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 re
The full text is at the source

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