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Outline

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

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

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)

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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”

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

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

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

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

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

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

Efficiencies

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