Dr. Dianne Murphy, M.D. Associate Director of Pediatrics September 12, 2000 Center for Drug Evaluation and Research Food and Drug Administration.

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Presentation transcript:

Dr. Dianne Murphy, M.D. Associate Director of Pediatrics September 12, 2000 Center for Drug Evaluation and Research Food and Drug Administration

PEDIATRIC RULE UPDATE Division Waivers DeferralsBoth Cardiorenal21 Neuropharm37 1 Oncology41 Med. Imaging-1 Anesthetic22 GI57 3 Metabolic925 2 Anti-Infective32

PEDIATRIC RULE UPDATE Division Waivers DeferralsBoth Anti-Viral-9 Derm/Dental63 Anti-Inflam83 1 OTC9- Pulmonary-7 Reproductive43 Special Pathogen44 2

 Cardiorenal26 / 24  Neuropharm25 / 18  Metabolic/Endo25 / 15  Anti-inflammatory22 / 36  Anti-viral20 / 20  Anesthetic/Abuse14 / 9  Derm/Dental13 / 7  Pulmonary12 / 9 PPSR’s / WR’s by Division

 GI11 / 5  Special Pathogens10 / 6  Oncology 5 / 3  OTC 4 / 3  Anti-infective 3 / 2  Reproductive 1 / 0  Medical Imaging 0 / 0 TOTAL 191 / 157 PPSR’s / WR’s by Division

AAP Invitational Meeting: Studying Oncology Drugs for Pediatric Use February 2000 AAP Academic Researchers Advocacy Representative NCI PhRMA Pediatric Cancer Cooperative Groups FDA