FDA Webinar: Overview: Clinical Pharmacology Considerations for Neonatal Studies

 February 15, 2023

1:00 PM - 2:00 PM ET

From the FDA notification with registration information:

ABOUT THIS WEBINAR

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

TOPICS COVERED

• Defining neonatal subpopulations that can be used for study design and study results reporting
• Clinical pharmacology and study design considerations for neonatal studies
• Innovative approaches to study design and analysis to address unique challenges in performing clinical trials in neonates

FDA SPEAKERS

A Pediatric Research Imperative: Addressing Neonates in Drug Development 

Dionna Green Director Office Pediatric Therapeutics (OPT) | Office of the Commissioner (OC) | FDA 

Clinical Considerations for Neonatal Drug Development 

An Massaro Supervisory Medical OfficerOPT | OC | FDA 

Clinical Pharmacology of Neonates and Considerations for Study Design 

Elimika Pfuma Fletcher Policy Lead and Senior Clinical Pharmacologist Office of Clinical Pharmacology (OCP) | Office of Translational Sciences (OTS) | CDER | FDA