FDA News: Issue 28, September 2021

Author: [AUTHOR] Published on 9/10/2021 5:00:00 AM

FDA Announces a Fetal Pharmacology and Therapeutics Public Workshop on October 21-22, 2021

The US 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 “Fetal Pharmacology and Therapeutics” on October 21-22, 2021, to discuss the current state of fetal pharmacology and therapeutics and how it pertains to pediatric drug development.

Fetal pharmacology has made significant advances in recent years and has moved into the “clinical science” space with considerations for both fetal therapeutics, allowing in-utero treatment of the fetus to avert postnatal disease as well as aversion of fetal toxicity from in-utero exposure to drugs following medications administered to the pregnant woman. This advance in knowledge requires addressing both the regulatory and scientific aspects of fetal pharmacology.

Workshop objectives:
  1. Review general regulatory and ethical considerations for fetal pharmacology and therapeutics
  2. Describe methods to assess clinical and nonclinical safety and efficacy assessments to support clinical trials of drugs in pregnancy and the fetus
  3. Highlight advances and existing knowledge in fetal therapeutics
  4. Discuss key aspects of maternal-fetal modeling and simulation

Workshop Information
The dates and times of the workshop are as follows:
Dates: October 21-22, 2021
Day 1: Thursday, October 21, 2021, from 10:00 AM to 3:15 PMET
Day 2: Friday, October 22, 2021, from 10:00 AM to 2:00 PM ET

Registration Information
This workshop is open to the public and is intended for clinicians, academicians, drug developers, and regulators, with no cost to attend. However, registration is required. For registration information, including a preliminary agenda please visit the M-CERSI website at https://cersi.umd.edu/event/16417/fda--m-cersi-fetal-pharmacology-workshop. You may register for remote access using the registration link at https://bioeumd.wufoo.com/forms/mza5izj0224pmu/.

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 prior to the meeting. You must log in with your username and password which you create when you register.

If you have any additional questions about this workshop, please contact Dr. Gilbert Burckart, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, phone 301-796-2065, email: gilbert.burckart@fda.hhs.gov.

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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