Military Use of Drugs Not Yet Approved by the FDA for CW/BW Defense: Lessons from the Gulf War

By Richard A. Rettig | Go to book overview

REFERENCES

21 Code of Federal Regulations §312.110, Miscellaneous, 1991.

21 Code of Federal Regulations §312.34, "Treatment Use of an Investigational New Drug," 1991.

21 Code of Federal Regulations §50, "Protection of Human Subjects," 1991.

52 Federal Register 33472, "Memorandum of Understanding Between the Department of Defense and the Food and Drug Administration," September 3, 1987.

55 Federal Register 52814, "Informed Consent for Human Drugs and Biologics; Determination That Informed Consent is Not Feasible," December 21, 1990.

62 Federal Register 40996, "Accessibility to New Drugs for Use in Military and Civilian Exigencies When Traditional Human Efficacy Studies Are Not Feasi- ble ; Determination Under the Interim Rule That Informed Consent is Not Feasible for Military Exigencies; Request for Comments," July 31, 1997.

Advisory Committee on Human Radiation Experiments, The Human Radiation Experiments: Final Report of the Presidential Advisory Committee, New York, Oxford University Press, 1996.

Annas, G. J., "Changing the Consent Rules for Desert Storm," New England Journal of Medicine, No. 326, 1992, pp. 770-773.

Annas, G., and M. A. Grodin, Commentary on "Treating the Troops" by EG Howe and ED Martin, Hastings Center Report, Vol. 21, No. 2, 1991, pp. 24-27.

Annas, G., and M. A. Grodin, The Nazi Doctors and the Nuremberg Code, New York: Oxford University Press, 1992.

Caplan, A., Testimony, U. S. Senate, Committee on Veterans' Affairs, "Is Military Research Hazardous to Veterans' Health? Lessons from World War II, the Persian Gulf, and Today," Hearing, May 6, 1994.

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Military Use of Drugs Not Yet Approved by the FDA for CW/BW Defense: Lessons from the Gulf War
Table of contents

Table of contents

  • Military Use of Drugs Not Yet Approved by the Fda for Cw/Bw Defense *
  • Preface v
  • Contents vii
  • Figure and Tables ix
  • Summary xi
  • Acknowledgments xvii
  • Glossary xix
  • Chapter One - Introduction 1
  • Chapter Two - The History of the Interim Rule 13
  • Chapter Three - What Uses of Drugs Are Investigational? 41
  • Chapter Four - The Interim Rule and Its Alternatives 59
  • Chapter Five - Broader Issues 81
  • Chapter Six - Conclusions and Recommendations 95
  • Chapter Seven - Postscript 97
  • References 99
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