Pediatric Reports of Interest

• 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