Pediatric Reports of Interest
Includes Congressionally Mandated Reports & Others
- Pediatric Labeling Changes under PREA, BPCA and the Pediatric Rule
- Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present (FDASIA)
- Reviews of Pediatric Studies Conducted under BPCA and PREA from 2007-2012 (FDAAA)
- Reviews of Pediatric Studies Conducted under BPCA from 2002 – 2007 (FDASIA)
This statistic includes pediatric studies conducted in response to a Written Request issued under the BPCA during the period 2002 - 2007.
- Summaries of Medical and Clinical Pharmacology Reviews
This information was required under BPCA 2002, but has not been updated since January 2008 due to changes in the law.
- Pediatric Tracking Requirements Under FDAAA
Pediatric labeling, pediatric study characteristics and other required statistical reports.
- Pediatric Exclusivity Granted
A list of active moieties granted pediatric exclusivity and indications studied.
- List of Determinations Including Written Request
Pediatric exclusivity determinations including written requests.
- Breakdown of FDAAA Completed Pediatric Studies
- Pediatric Exclusivity Statistics
The current number of Proposed Pediatric Study Requests and Written Requests issued by Review Division.
- Spectrum of Diseases/Conditions
A list of diseases by therapeutic area.
- Opinions and decisions on paediatric investigation plans
European Medicine Agency