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FDA News: Issue 31 October 2021

Author: [AUTHOR] Published on 10/1/2021 6:00:00 AM

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FDA Announces an Analgesic Clinical Trial Designs, Extrapolation, and Endpoints in Patients from Birth to Less Than Two Years of Age Public Workshop on October 13-14, 2021

The US Food and Drug Administration (FDA)’s Division of Pediatrics and Maternal Health (DPMH) in collaboration with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP) and the University of Maryland CERSI, is announcing a 2-day public workshop, “Analgesic Clinical Trial Designs, Extrapolation, and Endpoints in Patients from Birth to Less Than Two Years of Age” on October 13-14, 2021. The purpose of the public workshop is to discuss the current state of therapies to treat acute pain in children, identify data gaps, and consider methods to improve the current drug development paradigm for acute pain in patients less than 2 years of age (e.g., use of pediatric extrapolation, and novel clinical trial designs). The workshop is intended to focus on drugs with well-established mechanisms of action (NSAIDs, acetaminophen, local anesthetics, and opioids).

Workshop Information:
The public workshop will be held on the following dates and times:

Day 1: October 13, 2021 (10:00 am – 1:30 pm EST)
Day 2: October 14, 2021 (10:00 am – 3:00 pm EST)

The public workshop will be held in virtual format only. Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this public meeting via an online teleconferencing platform.

Webcast:
Registrants will receive webcast information once registered.

Agenda and Registration:
To access the agenda and registration for the public workshop, visit the following website: https://cersi.umd.edu/event/16557/analgesic-clinical-trial-designs-extrapolation-and-endpoints-in-patients-from-birth-to-under-age-2. There is no registration fee to attend this public workshop.

If you have any additional questions about this workshop, please contact Lily Mulugeta at yeruk.mulugeta@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://updates.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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