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Radiation and Nuclear Countermeasures Program

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Countermeasures Research and Development Program


NIAID/CMCR workshop on the FDA Pre-Market Regulatory Process: Applications to Radiation Countermeasures After a Large-Scale, Radiological Incident, June 9, 2006, Hilton Hotel, Gaithersburg, MD.

June 9, 2006, Meetings (Slides)

Drug Development Process and the Role of NIAID Regulatory Affairs (PDF). Presented by Jui Shah, Ph.D., Senior Regulatory Officer, Office of Regulatory Affairs (ORA), DAIT, NIAID, NIH.

Regulatory Pathways for Drug Development (PDF). Presented by Joanne Holmes, MBA, Associate Director for Regulatory Affairs, Office of Counter Terrorism and Emergency Coordination (OCTEC), Center for Drug Evaluation and Research (CDER), FDA.

Nonclinical Development of Biotechnology-Derived Products and Small Molecules… What are the Differences (PDF)? Presented by Melanie Hartsough, Ph.D., Pharmacologist, Office of New Drugs, CDER, FDA.

FDA Overview of Regulatory Expectations for INDs for Cellular and Gene Therapy Products (PDF). Presented by Richard McFarland, M.D., Ph.D., Acting Associate Director for Regulatory Policy, Office of Cellular, Tissue, and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), FDA.

Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Studies are not Ethical or Feasible or the "Animal Rule" (PDF). Presented by Martin Green, Ph.D., Supervisory Pharmacologist, Office of New Drugs, CDER, FDA.

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Last Updated June 12, 2006