FDA News: Issue 15-2 August 2022

Author: [AUTHOR] Published on 9/2/2022 1:50:00 PM

FDA Announces Availability of Multiple Internationally Harmonized Guidances of Interest to the Clinical Pharmacology Community

On August 28, 2022, the US Food and Drug Administration (FDA) announced the availability of the following guidances for industry of interest to the clinical pharmacology community, which were prepared under the support of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH):

E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential—Questions and Answers
This question-and-answer (Q&A) final guidance document is intended to clarify key issues to facilitate implementing the ICH guidances for industry E14 Clinical Evaluation of the QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (October 2012) and S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (October 2005). This guidance revises ICH E14 Q&As Q12 (5.1) and Q13 (6.1),and adds new ICH S7B Q&As Q17 (1.1) to Q30 (4.2). This guidance finalizes the draft guidance issued in September 2020.

M12 Drug Interaction Studies
The draft guidance is intended to decrease the risk of adverse events from interactions associated with taking more than one drug. Drug-drug interactions can sometimes lead to hospital admissions or reduced treatment efficacy. This draft guidance harmonizes international recommendations for in vitro and clinical evaluation of drug-drug interactions for a more consistent approach in design, conduct, and interpretation of enzyme and transporter-mediated interaction during the development of an investigational drug. This draft guidance also provides general recommendations on how to evaluate the pharmacokinetic drug interaction potential mediated via enzyme and transporter for investigational drugs.

E11A Pediatric Extrapolation
This draft guidance provides a comprehensive and systematic approach to the use of pediatric extrapolation during drug development, which, when used appropriately, can increase the efficiency of pediatric drug development and accelerate the availability of safe and effective drugs approved for use in children. The draft guidance provides alignment of terminology, information on various approaches that can be utilized to support the use of pediatric extrapolation, and a discussion of the types of study designs, statistical analyses, and modeling and simulation approaches that can be utilized. This guidance also aligns approaches to pediatric extrapolation globally so that there is greater likelihood of agreement in pediatric development programs across international regulatory authorities.

FDA publishes draft guidances to collect additional public comments. To submit your comments online regarding either the M12 or E11A draft guidances, click on the link to the draft guidance above and then click the ‘Submit Comments Online’ radio button. 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.

ICH’s goal is to foster development of uniform, scientifically driven, international standards to improve the efficiency of new drug development and promote public health by, among other things, preventing duplication of clinical trials and minimizing the use of animal testing. Within ICH, FDA collaborates with other international regulatory authorities and industry associations to harmonize global standards for the development of safe, effective, and high-quality medicines. These efforts are achieved through a transparent, science- and consensus-based process for guideline development that includes opportunities for public comment and a commitment of regulators to implement its guidelines and standards.

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 https://public.govdelivery.com/accounts/USFDA/subscriber/topics 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.

Sort by:
Photo Gallery
Recent News
Contact Us