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| Date | Title of guidance and link to document | Type and level of guidance | About the guidance |
|---|---|---|---|
| 30 Oct 2026 | E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential–Questions and Answers (R1) | Final, Level 2 | This question-and-answer (Q&A) document is intended to clarify key issues to facilitate implementing the International Council for Harmonisation (ICH) guidances for industry E14 Clinical Evaluation of the QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (October 2005) (ICH E14) and S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (October 2005) (ICH S7B). |
| 30 Oct 2026 | E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs | Final | This guidance provides recommendations to sponsors concerning the design, conduct, analysis, and interpretation of clinical studies to assess the potential of a drug to delay cardiac repolarization. This assessment should include testing the effects of new agents on the QT/QTc interval as well as the collection of cardiovascular adverse events. The investigational approach used for a particular drug should be individualized, depending on the pharmacodynamic, pharmacokinetic, and safety characteristics of the product, as well as on its proposed clinical use. |
| 30 Oct 2026 | S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals | Final | This guidance describes a nonclinical testing strategy for assessing the potential of a test substance to delay ventricular repolarization. The guidance includes information concerning nonclinical assays and integrated risk assessments. The assessment of the effects of pharmaceuticals on ventricular repolarization and proarrhythmic risk is the subject of active investigation. When additional data (nonclinical and clinical) are accumulated in the future, they will be evaluated and this guidance might be revised. |
| 20 Oct 2026 | Regulatory Considerations for Prescription Drug Use-Related Software | Final, Level 1 | This guidance describes how FDA intends to apply its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug product or a prescription drug-led, drug-device combination product (referred to as a combination product), i.e., a drug-device combination product that is assigned to the CDER or CBER as the lead center. |
| 13 Oct 2026 | Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers | Final, Level 1 | This guidance provides answers to commonly asked questions applicants regarding postapproval manufacturing changes made to licensed biosimilars and licensed interchangeable biosimilars. This Q&A guidance is intended to inform prospective and current applicants of the nature and type of information that applicants should provide in support of manufacturing changes to licensed biosimilars and licensed interchangeable biosimilars in different reporting categories. The recommendations in this guidance are intended to be consistent with the principles outlined in the ICH guidance for industry Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process (June 2005) (ICH Q5E). |
| 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 |