PREA gives FDA the authority to require pediatric studies in certain drugs and biological products. Studies must use appropriate formulations for each age group. The goal of the studies is to obtain pediatric labeling for the product.
- Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
Fulfills requirement that FDA post the PREA Non-Compliance letter and sponsor’s response.
- Pediatric Study Plan Template (PDF - 25 KB)
- Postmarket Requirements and Commitments Database
To view PREA postmarket requirements, check the Pediatric Research Equity Act box in the 'Required Under' section.
Automatic Full Waivers (PDF - 26 KB)
List of diseases for which FDA automatically grants a full waiver of pediatric studies.