Pediatric Science and Research Activities
To help advance the science and improve our understanding of how best to develop safe and effective products for children, the FDA conducts regulatory science research projects and publishes manuscripts describing scientific advances. The FDA also helps by creating opportunities and public forums for stakeholders to meet to discuss challenging scientific issues related to pediatric product development and pediatric regulatory science.
Advancing the Development of Pediatric Therapeutics (ADEPT) Workshops
Each year, the FDA hosts an ADEPT workshop to discuss ways to advance development of medicines for children.
- Enhancing Diversity in Therapeutics Development for Pediatric Patients (ADEPT-9) [September 6, 2024]
- Drug Dosing in Pediatric Patients with Renal Impairment (ADEPT 8) [November 30 – December 1, 2023] [ARCHIVED]
- Advancing the Development of Pediatric Therapeutics Complex Innovative Trial Design (ADEPT 7) [September 1-2, 2021] [ARCHIVED]
- Pediatric Clinical Trial Endpoints for Rare Diseases With a Focus on Pediatric Patient Perspectives (ADEPT 6) [November 12, 2019] [ARCHIVED]
- Advancing Pediatric Pharmacovigilance (ADEPT 5) [September 14, 2018] [ARCHIVED]
- Application of "Big Data" to Pediatric Safety Studies (ADEPT 4) [September 18-19, 2017] [ARCHIVED]
- Successes and Challenges of Performing Long-Term Pediatric Safety Studies (ADEPT 3) [April 13-14, 2016]
- Assessment of Pediatric Neurocognitive Outcomes (ADEPT 2) [April 17, 2015]
- Pediatric Bone Health (ADEPT 1) [March 4, 2014]