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What To Do in an Emergency
Acute Radiation Syndrome—A Fact Sheet for Physicians
Strategic National Stockpile
Safeguard America and Its Allies From Weapons of Mass Destruction
Office of Science and Technology Policy (OSTP)
Nuclear Blast Guidance
Nuclear Power Plant Emergency
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Center for Drug Evaluation and Research
The FDA "Animal Rule" (PDF)
Space Radiation Analysis Group
Division of Cancer Epidemiology and Genetics
Radiation Research Program
Ionizing Radiation Division
General Radiation Information
Low Dose Radiation Program
Radiation Event Medical Management (REMM)
Office of Public Health Emergency Medical Countermeasures (OPHEMC)
Disasters and Emergencies
Be Informed—Radiation Threat
Radiation Protection News Room
Space Radiation Program
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American Society for Therapeutic Radiology and Oncology (ASTRO)
International Atomic Energy Agency (IAEA)
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Health Physics Resources
Radiation Effects Research Foundation
Radiation Emergency Assistance Center/Training Site (REAC/TS)
Radiation Research Society (RRS)
Low Dose Radiation Research Site (DOE funded)
United States Transuranium and Uranium Registries (The National Radiobiology Archive)
Food and Drug Administration
Providing website 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 firstname.lastname@example.org. The email should include the name of the slideset(s), as shown below, and the meeting at which the slides were presented.
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.
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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U.S. Department of Health and Human Services Resources: Project Bioshield
On July 21, 2004, President Bush signed into law Project BioShield, which provides new tools to improve medical countermeasures protecting Americans against a chemical, biological, radiological, or nuclear (CBRN) attack.
Office of the Assistant Secretary for Emergency Preparedness and Response
Biomedical Advanced Research and Development Authority (BARDA)
Last Updated March 12, 2007