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An Overview of Medical Radiation Countermeasures National REP Conference April 14, 2005

An Overview of Medical Radiation Countermeasures National REP Conference April 14, 2005. CDR Michael A. Noska, USPHS Senior Health Physicist Center for Devices and Radiological Health Food and Drug Administration U.S. Department of Health and Human Services. What this talk is about:.

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An Overview of Medical Radiation Countermeasures National REP Conference April 14, 2005

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  1. An Overview of Medical Radiation CountermeasuresNational REP Conference April 14, 2005 CDR Michael A. Noska, USPHS Senior Health Physicist Center for Devices and Radiological Health Food and Drug Administration U.S. Department of Health and Human Services

  2. What this talk is about: • Overview of currently approved medical countermeasures • Federal programs for countermeasure development • Mechanisms for emergency use

  3. What this talk is notabout: • KI DISTRIBUTION!!! • Off-label uses • Investigational products

  4. FDA Regulatory Review • IND/IDE • NDA/PMA/510K • Accelerated approval • Bioterrorism Act of 2002 • Emergency Authorization • Animal Rule

  5. Potassium Iodide (KI) • Prophylaxis against uptake of *I • Dosing • Supplied as 65 or 130 mg tablet • >40 yo, >500 rem: 130 mg/day • 18-40, >10 rem: 130 mg/day • 3-18 yo, preg/lact: 65 mg/day • 1 mo-3 yo: 32 mg/day • Birth to 1 mo: 16 mg/day • Bioterrorism Act • Shelf-life extension

  6. Prussian Blue (Radiogardase™) • Radioeliminator for *Cs and Tl • Binds and reduces GI re-absorption • Dosing • Supplied as 500 mg tablet • Adult: 3 g three times a day for 30 days • Children 2-12 yo: 1 g three times a day for 30 days • Routes of administration • Side effects: gastric distress

  7. DTPA • Increases rate of elimination of certain transuranics (Pu, Am, Cm) • Ca and Zn analogs • Dosing • Supplied as clear sterile liquid for injection • Adult: 1 g Ca first day + 1 g Ca/Zn following • Pediatric (<12 yo): 14 mg/kg Ca; 14 mg/kg Ca/Zn • Routes of administration • IV • Nebulizer • RFI for oral

  8. Ancillary topics • Cytokines (Biological response modifiers) • Neupogen • Strategic National Stockpile (SNS)

  9. Medical Countermeasure Development • HSC/OSTP RDD/IND Working Group • Medical Countermeasures Sub-group • DHS/S&T Interagency WG • NIH/NIAID Centers of Excellence • HHS/Project Bioshield Act of 2004 grants for focused product development • FDA Inter-Center WG on MCM

  10. Contact Information FDA www.fda.gov www.fda.gov/oc/opacom/hottopics/bioterrorism.html FDA Emergency Operations Center 301-443-1240, 800-759-8352 Mike Noska, CDRH/OCER/DMQRP/RPB 301-594-3527 man@cdrh.fda.gov

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