FDA News: Issue 2-2 February 2023

Author: [AUTHOR] Published on 2/3/2023 6:00:00 AM

FDA Announces a Public Webinar on Clinical Pharmacology Considerations for Neonatal Studies

On February 15, 2023, the US Food and Drug Administration’s (FDA’s) Small Business and Industry Assistance (SBIA) will hold a one-hour webinar entitled "Overview: Clinical Pharmacology Considerations for Neonatal Studies." The purpose of this webinar is to share information on clinical pharmacology and study design considerations for clinical studies in neonates, and innovative study design and analysis approaches to address the unique challenges in performing clinical studies in neonates. 

In this webinar, FDA will discuss:
  • An overview of the current status and the gaps related to the inclusion of neonates in drug development
  • Clinical pharmacology considerations for planned studies in neonates
  • General pharmacokinetic, pharmacodynamic, and pharmacogenomic considerations for clinical pharmacology studies in neonates
  • Unique clinical and study design considerations for studying neonates
  • Innovative approaches that can be incorporated into study design to address unique challenges in neonates
Date/Time of the Webinar:
Date: February 15, 2023
Time: 1:00 PM – 2:00 PM ET

This virtual webinar is open to the public; however, registration is required at the SBIA registration website. More information about this event can be found at the Clinical Pharmacology Considerations for Neonatal Studies webinar website. This webinar is intended for regulators and regulatory professionals, researchers, clinical research coordinators, consultants, and healthcare providers involved in the study or submission of clinical pharmacology studies involving neonates.

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.

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