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FDA Corner


Providing Web site resources, presentations, and information relevant to the policies and procedures of the Food and Drug Administration.

To receive copies of any of the available presentations listed below, please send an email to cohena@niaid.nih.gov. The email should include the name of the slideset(s), as shown below, and the meeting at which the slides were presented.

Meetings

NIAID/CMCR Workshop on the FDA Pre-Market Regulatory Process: Applications to Technologies for Radiation Biodosimetry After a Large-Scale Radiological Incident, March 27, 2006, Bethesda, MD.

March 27, 2006, Meetings (Slides)

The FDA Pre-Market Regulatory Process (PDF, 1.73 MB), presented by Mary Pastel, Associate Director for Advanced In Vitro Diagnostics, Office of In Vitro Diagnostic Device Evaluation and Safety and Office of Science and Engineering Laboratories, Center for Devices and Radiological Health (CDRH), FDA.

Pre-IDE Processing (PDF), presented by Sousan Altaie, Scientific Policy Advisor, Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH, FDA.

Data Analysis: Software and Statistics (PDF), presented by Estelle Russek-Cohen, Team Leader and Mathematical Statistician, Diagnostic Devices Branch, Division of Biostatistics, Office of Surveillance and Biometrics, CDRH, FDA.

Role of the Clinical Laboratory Improvement Amendments (CLIA) Program (PDF), presented by James Cometa, Team Leader/Program Analyst, Centers for Medicare & Medicaid Services, Survey and Certification Group, Division of Laboratory Services.

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), Division of Allergy, Immunology, and Transplantation (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 January 22, 2009