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 Public Meeting - Radioactive Drugs for Certain Research Uses
November 16, 2004

Presentations

FDA Staff

  • RDRC: Examples of Appropriate Studies, Jerry M. Collins, Ph.D., FDA. [HTML] or [PPT]

  • Membership and Administrative Issues, Richard M. Fejka, MS, RPh, BCNP, FDA. [HTML] or [PPT]

  • Pediatric Studies and RDRC, Sara F. Goldkind, M.D., M.A., FDA. [HTML] or [PPT]

  • Quality and Purity Standards in the Production of Radioactive Drugs under RDRC, Eldon E. Leutzinger, Ph.D., FDA. [HTML] or [PPT]

  • RDRC -  No Clinically Detectable Pharmacological Effect, Sally Loewke, M.D., FDA.  [HTML] or [PPT]

  • RDRC and the Safety of Women of Child-Bearing Potential, Sally Loewke, M.D., FDA.  [HTML] or [PPT]

  • Radioactive Drugs for Certain Research Uses, George Mills, M.D., FDA.  [HTML] or [PPT]

  • The Study of Radioactive Drugs in Human Subjects -- RDRC vs IND: A Comparison, Lynn Panholzer, Pharm.D., FDA  [HTML] or [PPT]

  • RDRC Radiation Dose Limits, Orhan H Suleiman, MS, Ph.D., FAAPM, FDA. [HTML] or [PPT]

Public Presentations

  • Presentation on RDRC Membership, Terence Beven, M.D., American College of Nuclear Physicians (ACNP). [HTML] or [PPT]

  • Microdosing - First in Human Studies, Michael Chansler, Accium BioSciences. [HTML] or [PPT]

  • The Microdose Concept, Colin Garner, BPharm, Ph.D., D.Sc., FRCPath, Xceleron Ltd, UK. [HTML] or [PPT]

  • Pediatric Nuclear Medicine and the RDRC Regulations, Michael J. Gelfand M.D., Cincinnati Children’s Hospital, Society of Nuclear Medicine. [HTML] or [PPT]

  • Dose Limits for Studies Under an RDRC, Eric J. Hall, D.Phil., D.Sc., F.A.C.R., F.R.C.R., Columbia University. [HTML] or [PPT]

  • Radiation Dose Limits for Adult Subjects, Henry D. Royal, M.D., Washington University School of Medicine. [HTML] or [PPT]

  • Exclusion of Pregnant Women, Henry D. Royal, M.D., Washington University School of Medicine. [HTML] or [PPT]

  • RDRC Review of Biologics, Gary T. Smith, MD, University of Tennessee.  [HTML] or [PPT]
  • The RDRC and “first in man” studies, Andrew Taylor, M.D., Emory University School of Medicine. [HTML] or [PPT]
  • Pharmacology Issues: SNM Suggestions, Mathew L. Thakur, Ph.D., Society of Nuclear Medicine. [HTML] or [PPT]
  • RDRC Membership: SNM Suggestions, Mathew L. Thakur, Ph.D., Society of Nuclear Medicine. [HTML] or [PPT]
  • Use of Effective Dose as an RDRC Study Limit, Wayne L Thompson, University of Tennessee Medical Center. [HTML] or [PPT]
  • Statement of Dr. Kim A. Williams, American Society of Nuclear Cardiology. [HTML] or [PPT]

Back to Top     Public Meeting - Radioactive Drugs

Date created: November 24, 2004, updated November 30, 2004
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