FDA News: Issue 21, July 2020

Author: [AUTHOR] Published on 8/3/2020 11:00:00 AM

FDA Announces a Pediatric Dose Selection Public Workshop for October 22 - 23, 2020

The Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will host a two-day virtual public workshop entitled "Pediatric Dose Selection" on October 22 and 23, 2020 to discuss the present state of dose selection and how it pertains to pediatric drug development.

Dose selection for new drug products remains a critical part of pediatric drug development. A variety of techniques have been used to predict the pediatric dose, but the prediction is generally based on no or incomplete pharmacokinetic data. The workshop aims to review the current methods used to determine the pediatric dose and address ways to overcome dose selection challenges seen in pediatric drug development.

Workshop Objectives
The objectives of this workshop are to:
  1. To review the current methods of pediatric dose selection;
  2. To discuss how to address the gaps in pediatric dose selection that occur because of the inability to perform studies in pediatric patients;
  3. To evaluate future approaches to pediatric dose selection in all pediatric patient populations.
Workshop Information
The date, time, and other details of the workshop are as follows:
Date: October 22 - 23, 2020
Day 1: Thursday, October 22, 2020, 10:00 AM to 3:00 PM ET
Day 2: Friday, October 23, 2020, 10:00 AM to 12:30 PM ET

Registration Information
Information about this event, including details about registration and an agenda, is available at https://www.pharmacy.umaryland.edu/centers/cersievents/pedsdoseselection/. To register, please visit: https://www.eventbrite.com/e/pediatric-dose-selection-tickets-107974167642. This workshop is intended for clinicians, drug developers, and regulators.

This virtual public workshop will be available to view via webcast, but pre-registration is still required. You will receive the link to access the live webinar several weeks prior to the meeting. You must log in with your username and password which you create when you register.

If you have questions about the workshop or registering for the meeting, contact Gilbert Burckart, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, phone: 301-796-2065, or email gilbert.burckart@fda.hhs.gov or Ann Anonsen at aanonsen@umd.edu.

If you have any additional questions about this workshop, please contact cersi@umd.edu.

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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