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Statistical Update

Statistical Update. March 3, 2003. Terrie L. Crescenzi, RPh Associate Director for Regulatory Affairs Office of Counter-Terrorism & Pediatric Drug Development Center for Drug Evaluation and Research Food and Drug Administration. Pediatric Exclusivity. Proposals from Industry 324

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Statistical Update

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  1. Statistical Update March 3, 2003 Terrie L. Crescenzi, RPhAssociate Director for Regulatory Affairs Office of Counter-Terrorism & Pediatric Drug Development Center for Drug Evaluation and Research Food and Drug Administration

  2. Pediatric Exclusivity • Proposals from Industry 324 • FDA issued Written Requests 264 • Exclusivity Determinations 82 • Exclusivity Granted 73 • New Labeling 49

  3. Studies Breakdownfor 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

  4. 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

  5. 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

  6. 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

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