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| Date | Title of guidance and link to document | Type and level of guidance | About the guidance |
|---|---|---|---|
| 8 Oct 2026 | Study Data Technical Conformance Guide – Technical Specifications Document | Final | This Guide provides technical recommendations to sponsors for the submission of animal and human study data and related information in a standardized electronic format in INDs, NDAs, ANDAs, and BLAs. The Guide is intended to complement and promote interactions between sponsors and FDA review divisions. However, it is not intended to replace the need for sponsors to communicate directly with review divisions regarding implementation approaches or issues relating to data standards. |
| 7 Oct 2026 | Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing | Draft, Level 1 | This guidance assists sponsors in the design and analysis of studies that assess the influence of impaired hepatic function, herein referred to as hepatic impairment (HI), on the pharmacokinetics and, where appropriate, the pharmacodynamics of a drug. This guidance provides recommendations on the following topics: • When studies to assess the influence of HI on the pharmacokinetics or pharmacodynamics of a drug should be conducted and when they may not be warranted • Design and conduct of studies to characterize the effects of HI on the pharmacokinetics of a drug, including the population pharmacokinetic (popPK) approach • Data analysis and interpretation of these study results, as well as the evaluation of relationships between measures of hepatic function and pharmacokinetic and/or pharmacodynamic parameters |