- Off-Patent Studies under BPCA
- Products Waived for The Inability to Develop A Pediatric Formulation – A listing of those products that received a partial waiver under PREA because of the inability to develop a pediatric formulation.
- Pediatric Labeling Changes under PREA, BPCA and the Pediatric Rule
- Full Reviews of Pediatric Studies conducted under BPCA and PREA
- Pediatric Tracking Requirements
Pediatric labeling, pediatric study characteristics and other required statistical reports.
- Pediatric Exclusivity Granted
A list of active moieties granted pediatric exclusivity and indications studied.
- Pediatric Exclusivity Determinations List (PDF - 98 KB)
- Pediatric Exclusivity Statistics
The current number of Proposed Pediatric Study Requests and Written Requests issued by Review Division.
- Written Requests Issued
List of approved active moieties and the sponsor to whom the written request was issued.
- List of Determinations Including Written Request
Pediatric exclusivity determinations including written requests.
- Spectrum of Diseases/Conditions
A list of diseases by therapeutic area.
- Opinions and decisions on paediatric investigation plans External
European Medicine Agency
- Pediatric Formulations Developed to Earn Pediatric Exclusivity But Not Marketed (PDF - 19 KB)
- Historical References