Analgesic Clinical Trial Designs, Extrapolation, and Endpoints in Patients from Birth to Under Age 2

Wednesday, October 13, 2021
10:00 a.m.-2:00 p.m.

Analgesic Clinical Trial Designs, Extrapolation, and Endpoints in Patients from Birth to Less Than Two Years of Age

Wednesday, October 13 (10:00 a.m. - 1:30 p.m. EST)

Thursday, October 14, 2021 (10:00 a.m. - 3:00 p.m. EST)

Virtual - via Adobe Connect

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Preliminary Agenda

Speaker Bios

Collaborative workshop hosted by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the Food and Drug Administration (FDA)

About the Event:

FDA’s Division of Pediatrics and Maternal Health in collaboration with the Division of Anesthesiology, Addition Medicine, and Pain Medicine (DAAP) and The University of Maryland CERSI, are announcing a 2-day public workshop, “Analgesic Clinical Trial Designs, Extrapolation, and Endpoints in Patients from Birth to Less Than Two Years of Age”.  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, opioids), rather than drugs with novel mechanisms of action.

The workshop will be open to the public. 

Contact:

Ann Anonsen (aanonsen@umd.edu)

This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005946 totaling $25,000 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.


 

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