NonprescriptionAnalgesic/Antipyretic Drug Development in Children 2 to Less Than 12 Years of Age
Friday, November 15, 2024
Friday, November 15, 2024
9-9:10 a.m.
Welcome and Opening Remarks
Nushin Todd, Director, Divisionof Nonprescription Drugs 1 (DNPD1)
U.S. Food and Drug Administration (FDA)
9:10-9:20 a.m.
Introductory Remarks
Theresa Michele, Director, Office of Nonprescription Drugs, FDA
9:20-9:35 a.m.
Regulatory Background for Children’s Nonprescription Pain and Fever Products
Shila Azodi, Medical Officer, DNPD1, FDA
9:35-9:45 a.m.
Pediatric Research Equity Act (PREA)
Ndidi Nwokorie, Medical Officer, Division of Pediatrics and Maternal Health (DPMH), FDA
9:45-10 a.m.
Clinical Considerations for OTC Antipyretic-Analgesics Among 2–12-Year-Old Children
Ian Paul, University Professor of Pediatrics, Pediatrician, Penn State College of Medicine
10-10:15 a.m.
Current Perspectives on Consumer Use of Nonprescription Pain and Fever Products and Potential Unmet Needs: Epidemiology of SymptomsDiane Hindman, Attending Physician, University of Arizona College of Medicine
10:15-10:30 a.m.
Collaboration Leads to Improved OTC Solutions for Children
Leanne West, President, International Children’s Advisory Network
Casey Cashman, Director, Pediatric Pain Warrior, U.S. Pain Foundation
10:30-10:45 a.m.
Patient Perspectives: Case Study Series
Jody Thomas, Founder/CEO, Meg Foundation
10:45-11 a.m.
The National Consumers League
Sally Greenberg, Chief Executive Officer, National Consumers League
11-11:15 a.m.
Break
11:15 a.m.-12:15 p.m.
Panel Discussion
Recruitment and Retention/Decentralized Trials-15 min
John Alexander, Deputy DivisionDirector, DPMH, FDA
Corrie Chumpitazi, Pediatric Emergency Medicine Specialist, Duke Department of Pediatrics
Samina Ali, Professor, Department of Pediatrics, University of Alberta, Canada
Susan Sirota, Founding Partner and CEO, PediaTrust LLC
12:15 a.m.-1 p.m.
Lunch
1-1:15 p.m.
Protecting Access to Pain Relief (PAPR) Coalition
Wade Delk, Board Member and Treasurer, Protecting Access to Pain Relief Coalition
1:15-1:30 p.m.
Preventing Pediatric Medication Overdose: Strategies, Challenges and Innovations
Maribeth Sivilus, Epidemiologist, CDC Protect
Jennifer Lind, Partnership and Prevention Lead, Medication Safety Program, CDC Protect
1:30-1:45 p.m.
Lessons from Product Safety Changes to Reduce Pediatric Medication Errors to Acetaminophen (Poison Center Analysis)
Kate Reynolds, Director of Research, Rocky Mountain Poison and Drug Safety
1:45-2 p.m.
Changes to Existing Product Characteristics – the Pharmacist Prospective
Petrea Cober, Professor of Pharmacy Practice,Northeast Ohio Medical University
2-2:15 p.m.
Nonprescription Analgesic/Antipyretic Drug Development in Children 2 to <12 years of Age: A Health Literacy Perspective
Shonna Yin, Associate Professor Pediatrics,New York University
2:15-2:30 p.m.
Consumer Behavior Research: Evaluating When Product Characteristics Might Introduce Problems for Consumers
Russ Bradford, Senior VP Medical Affairs, PEGUS Research
2:30-2:40 p.m.
Break
2:40-3:40 p.m.
Panel Discussion
Moderators:
Dorothy Chang, Deputy Director for Safety, DNPD1, FDA
Mona Khurana, Medical Team Leader, DPMH, FDA
Panelists (in addition to Speakers):
Casey Cashman, Director, Pediatric Pain Warrior, U.S. Pain Foundation
Diane Hindman, Attending Physician, University of Arizona College of Medicine
Routt Reigart, Professor Emeritus of Pediatrics, Medical University of South Carolina
Jonathan Zipursky, Clinician-Scientist, Sunnybrook Research Institute, Toronto, Canada
3:40-4 p.m.
Closing Remarks and Next Steps
Lynne Yao, Division Director, DPMH, FDA
This workshop is co-hosted by the U.S. Food and Drug Administration (FDA) and the Center of Excellence in Regulatory Science and Innovation (M-CERSI).
