Division of Pediatric and Maternal Health - Pediatric Summaries, Full Reviews, Statistics & Pediatric Exclusivity Determinations

• 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
  • Reviews of Pediatric Studies conducted under BPCA and PREA from 2012 to present
  • Reviews of Pediatric Studies conducted under BPCA and PREA from 2007 to 2012
  • Reviews of Pediatric Studies conducted under BPCA from 2002 to 2007
• 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)
• 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• Historical References