The U.S. 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://urldefense.com/v3/__https:/lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDAsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMTA5MjQuNDY0MjYzNTEiLCJ1cmwiOiJodHRwczovL2NlcnNpLnVtZC5lZHUvZXZlbnQvMTY1NTcvYW5hbGdlc2ljLWNsaW5pY2FsLXRyaWFsLWRlc2lnbnMtZXh0cmFwb2xhdGlvbi1hbmQtZW5kcG9pbnRzLWluLXBhdGllbnRzLWZyb20tYmlydGgtdG8tdW5kZXItYWdlLTI_dXRtX21lZGl1bT1lbWFpbCZ1dG1fc291cmNlPWdvdmRlbGl2ZXJ5In0.hwEa90NQWuDtoJQAUh0U3U5gKC-JgdhQEbaLqg0TWE8/s/1255637289/br/112882137129-l__;!!KDurfCY!uo9EvEUSTyP9MrsrdkvgQwST-YY-OXA-b-t1b8DDNJxsJkaGmrKjjDQNaM9hor07mg$.
There is no registration fee to attend this public workshop.
If you have any additional questions about this workshop, please contact Lily
Mulugeta at [email protected]<mailto:[email protected]>.
Best regards,
Lily Mulugeta, PharmD
Associate Director, Policy and Research
Division of Pediatrics and Maternal Health, ORPURM
Office of New Drugs
Center for Drug Evaluation and Research
U.S. Food and Drug Administration