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Pediatrics Update

Pediatrics Update

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Pediatrics Update

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  1. Pediatrics Update Dianne Murphy, M.D. Director, Office of Pediatric Therapeutics Office of the Commissioner Director, OCTAP Center for Drug Evaluation March 3, 2003

  2. Pediatrics Update • Organization of Pediatrics - D. Murphy • New Office of Pediatric Therapeutics - D. Murphy • Overview of Postmarketing Safety Surveillance in FDA – M. Chen • Adverse Events Reporting - S. Iyasu • Division of Pediatric Drug Development - S. Murphy • Statistics - T. Crescenzi

  3. Historical Perspective Office of Pediatric Drug Development and Program Initiatives (OPDDPI) Office of Counter-Terrorism & Pediatric Drug Development (OCTAP) Division of Pediatric Drug Division of Counter-Terrorism Development (DCT) (DPDD)

  4. Pediatrics Structure Office of the FDA Commissioner International Activities & Strategic Initiatives CDER Office of Pediatric Therapeutics OCTAP Division of Pediatric Drug Development

  5. Office of Pediatric Therapeutics • How established? • Best Pharmaceuticals for Children Act (1/4/02) • Section 6 • Duties? • “Coordination and facilitation of all activities of FDA that may have any effect on a pediatric population OR • the practice of pediatrics OR • may in any way involve pediatric issues”

  6. Office of Pediatric Therapeutics Staff: • One or more individuals with expertise concerning ethical issues • position currently being advertised in NEJM • One or more experts in Pediatrics • Solomon Iyasu, M.D., M.P.H. • adverse event reporting

  7. Office of Pediatric Therapeutics Two important functions that impact you • Subpart D • Adverse Event Reporting

  8. Office of Pediatric Therapeutics Subpart D • FDA regulated products • Expert panel to be convened because of referral from an IRB

  9. Office of Pediatric Therapeutics Adverse Event Reporting • Drugs with Pediatric Market Exclusivity • Any adverse event reports must be referred to the Office of Pediatric Therapeutics for a one-year period from the date a drug receives pediatric exclusivity. • Review of reports by Pediatric Advisory Subcommittee

  10. Office of Pediatric Therapeutics Adverse Event Reporting • Partnership between Office of Drug Safety (ODS) and Office of Pediatric Therapeutics (OPT) • ODS - How they collect adverse events • OPT - Solomon Iyasu, M.D., M.P.H. • How we will report adverse events to you

  11. Office of Pediatric Therapeutics • How to avoid overlap and duplication with Division of Pediatric Drug Development? • Solution = Efficiencies

  12. Efficiencies

  13. Office of Pediatric Therapeutics How to Contact Us? Email: opt@fda.gov Phone: 301-827-9218 Fax: 301-827-4001