Event

Nonprescription Analgesic/Antipyretic Drug Development in Pediatric Patients 2 to Less Than 12 Years

Friday, November 15, 2024
9:00 a.m.-5:00 p.m.
FDA White Oak Campus, Silver Spring Maryland
ONDPublicMTGSupport@fda.hhs.gov
https://lu.ma/0qbphzm6

Nonprescription Analgesic/Antipyretic Drug Development in Pediatric Patients 2 to Less Than 12 Years of Age

Date & Time
November 15, 2024 9:00 a.m. - 5:00 p.m.

Location
Building 31, FDA Great Room
FDA White Oak Campus
10903 New Hampshire Avenue
Silver Spring, MD 20903

Organized By

CDER Office of New Drugs 
M-CERSI 

About This Event

This public workshop will be hosted by the FDA/CDER Office of New Drugs in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI). The goal of the workshop is to discuss the current nonprescription analgesic/antipyretic treatment options available for children 2 to less than 12 years of age and the development needs for additional oral nonprescription treatment options containing acetaminophen and/or nonsteroidal anti-inflammatory drugs (NSAIDs) for pain, fever, or both for the same pediatric population.

Background

Many new pain or pain and fever products being developed as new drugs for nonprescription use are subject to the requirements of the Pediatric Research Equity Act (PREA). It is unclear if there is an unmet need among children 2 to less than 12 years of age who have “minor aches and pains due to the common cold, sore throat, flu, headache, toothache, or fever” that should require pediatric development. Additionally, there is ambiguity regarding the extent to which expanding the nonprescription analgesic/antipyretic treatment options for this age group might lead to consumer confusion, considering the availability of multiple products containing similar ingredients for the same indication.

​Topics for Discussion
The topics we will be exploring are:

• ​whether there is a need to develop new nonprescription analgesics and antipyretics containing acetaminophen or NSAIDs, either alone or in combination to reduce pain and fever.

• ​what drug characteristics would represent a therapeutic benefit over current treatment options.

• ​what pediatric subpopulations (e.g., age groups) would benefit from these new nonprescription drugs for the already established labeled uses (for temporary relief for minor aches and pains due to the common cold, sore throat, flu, headache, toothache, fever reduction).

• ​to consider what the potential unintended consequences may be related to introducing more products containing similar ingredients for the same indication in this age group, particularly in relation to consumer confusion. 

Agenda

Please check back for an agenda.

Registration

Registration is free.  All interested parties are encouraged to register early.

This workshop will be held on-site and in virtual format. Registration is required for both in-person and virtual attendance. On-line registration will be available until 5:00 PM ET on Thursday, November 14, 2024. Registrants will receive confirmation when they register.

On-Site Attendance

For information related to on-site attendance, please refer to FDA.gov.
https://www.fda.gov/about-fda/visitor-information/public-meeting-information

Visitor Parking and Campus Map

https://www.fda.gov/about-fda/visitor-information/visitor-parking-and-campus-map

Campus Access and Security

https://www.fda.gov/about-fda/visitor-information/campus-access-and-security

Entrance for public workshop attendees (non-FDA employees) is through Building 1. Non-FDA attendees will be required to present a government-issued ID (e.g., passport, driver's license) before going through security.  After passing through security screening, attendees will be directed to the workshop room in Building 31.

Food and Beverage Options:

Coffee, beverages, light breakfast items, crafted artisan salads and sandwiches will be available for purchase at the kiosk. The kiosk is the only accessible vendor to purchase food and beverage to non-FDA employees. Please note, the kiosk closes at 2:00 PM ET, should you need an afternoon snack or beverage.

Special Accommodations

The FDA will make every effort to accommodate persons with physical disabilities or special needs at public meetings. If you require accommodations due to a disability, email ONDPublicMTGSupport@fda.hhs.gov at least 7 days before the workshop. The FDA White Oak campus and FDA shuttle are generally accessible to people with physical disabilities.

Virtual Attendance (Zoom Webinar)

This meeting will be available for virtual viewing on the days of the meeting via Zoom. All information will be sent to attendees prior to the workshop. If you are unable to download Zoom, you can also use the browser version of Zoom for viewing this workshop.

Contact

For additional details, contact the FDAs CDER/OND/Public Meeting Support Team at ONDPublicMTGSupport@fda.hhs.gov.

Funding Statement

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 to the Center of Excellence in Regulatory Science & Innovation, U01FD005946 totaling $17,205 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.