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Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage; Draft Guidance for Industry; Availability
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Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled "Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage."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 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.
- Document type
- Notice
- Federal Register document number
- 2026-17961
- Published
- Sep 2, 2026
- Action
- Notice of availability.
- Docket
- FDA-2026-D-8693
- Comments posted on Regulations.gov (at last check)
- 0
- DATES section (from the document)
- Submit either electronic or written comments on the draft guidance by December 1, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Topics (auto-tagged)
- Vaccines / biologics
Source: Federal Register API, document 2026-17961. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.