The Food and Drug Administration (FDA) is announcing a public workshop entitled “Advancing the Development of Pediatric Therapeutics (ADEPT): Successes and Challenges of Performing Long-Term Pediatric Safety Studies”.
The purpose of this two day workshop is for FDA to have an open discussion with experts in the field regarding the length of pediatric safety studies. Day 1 will focus on an exposition of the successes and challenges of long-term safety studies in children. Day 2 will focus on suggestions for the future on study design and implementation for long-term safety studies in children. Viewpoints of patient representatives of children with long-term conditions and industry will be included.
April 13-14, 2016
8:00 a.m. to 5:00 p.m.
DoubleTree by Hilton Hotel - Bethesda
8120 Wisconsin Avenue, Bethesda, Maryland 20814
To register for this workshop, visit the workshop registration page
Seating will be limited so please register before close of business on April 7, 2016.
- Federal Register Notice
- Final Agenda
- Speakers' Biographies
- Transcript for April 13 Workshop
- Transcript for April 14 Workshop
- Webcast: Public Workshop - ADEPT Long-Term Pediatric Safety Studies April 13, 2016 Part 1
- Webcast: Public Workshop - ADEPT Long-Term Pediatric Safety Studies April 13, 2016 Part 2
- Webcast: Public Workshop - ADEPT Long-Term Pediatric Safety Studies April 14, 2016
For questions regarding the workshop please contact:
Renan A. Bonnel Pharm.D, MS, MPH
Office of Pediatric Therapeutics
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993–0002