FDA Guides Drug Tests for Bad Livers: Dosage Drama Ahead
Published Date: 9/2/2026
Notice
Summary
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled "Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage."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.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Draft FDA Guidance for Drug Sponsors
If you develop drugs or biologics, the FDA released a draft guidance to help sponsors design and analyze studies that assess how impaired liver (hepatic) function affects a drug's pharmacokinetics and, where appropriate, pharmacodynamics. The draft applies to drugs and therapeutic biological products and the Agency is accepting comments through December 1, 2026.
Safer Dosing for Liver Disease Patients
If you have liver disease, the FDA's draft guidance encourages drug developers to study how hepatic impairment changes how drugs are processed, which can lead to different recommended dosages for patients with impaired hepatic function. The guidance also says using early characterization and modeling can help include patients with hepatic impairment in clinical trials; comments are due by December 1, 2026.
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