Notes
Slide Show
Outline
1
Statistical Update
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3
Pediatric Exclusivity
  • Proposals from Industry 324
  • FDA issued Written Requests 264
  • Exclusivity Determinations 82
  • Exclusivity Granted 73
  • New Labeling 49
4
Studies Breakdown
for Issued WRs
  • Efficacy & Safety 215   (35%)
  • PK & Safety 185   (30%)
  • PK/PD   57   (9%)
  • Safety   98   (16%)
  • Other   61   (9%)


  • Total Studies 616
  • Projected # of patients 36,388
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6
Pediatric Rule
(Apr 99 – Dec 02)
  • Total # of Applications 517
  • Waivers 263
  • Deferrals 206
  • Applications with Completed Studies 130
  • Applications with Completed Studies
  •   not assoc. Pediatric Exclusivity 54
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Pediatric Rule
  • Reason for Concern!


  • Sponsors requesting waivers after previously receiving a deferral of studies
  • Discussion of pediatrics early in drug development & at key meetings
9
To Contact Us:
  • OPT Line:
  • 301-827-9218



  • OCTAP Line:
  • 301-827-7777


  • Peds Line:
  • 301-594-PEDS


  • Internet:
  • www.fda.gov/cder/pediatrics


  • Email:
  • opt@fda.gov
  • pdit@cder.fda.gov