FDA News: Issue 30, October 2020

Author: [AUTHOR] Published on 10/5/2020 9:35:00 AM

FDA Announces Availability of a Draft Guidance, E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential - Questions and Answers

On September 30, 2020, the US Food and Drug Administration (FDA) announced the availability a draft guidance for industry titled "E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential -- Questions and Answers." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and contains revised questions and answers (Q&As) for the ICH guidances for industry, "E14 Clinical Evaluation of the QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs" and "S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals." This draft guidance provides recommendations on considerations for an integrated risk assessment combining nonclinical and clinical data, in particular, at later stages of drug development when clinical data are available. The draft guidance intends to provide a harmonized approach to integrate nonclinical and clinical information for proarrhythmia risk assessment to streamline drug development and provide clarity on regulatory decision-making.

The FDA will be hosting a free, two-day public webinar on October 15-16, 2020 titled "New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment " to cover the background, motivation for, and overview of the new Q&As for ICH E14/S7B. Additional details about this webinar, including registration, agenda, and supplementary resources such as the original E14/S7B Guidelines (May 2005), Work Plan (April 2020), and Concept Paper (2018), are available at: https://go.usa.gov/xGEcx.

The "E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential -- Questions and Answers" guidance is available at: https://go.usa.gov/xGwGA. Please refer to the draft guidance for more details. FDA is publishing this draft guidance to collect additional public comments. You may submit your comments regarding the draft guidance to the docket (Docket No. FDA-2020-D-1791) available at https://www.regulations.gov up to 60 days following publication in the FEDERAL REGISTER. This draft guidance, when finalized, will represent the current thinking of the FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. Your comments do make a difference and can impact the outcomes of FDA regulatory policy. Share your knowledge and experience and make your voice count.

The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at http://go.fda.gov/subscriptionmanagement (note: this link does not work with Internet Explorer) and select Clinical Pharmacology Corner under Drugs.

We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.

This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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