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and Medicine 58:9–17.

6.  

Comment by Dr. Bonnie Goldmann (Senior Director, Regulatory Affairs, Merck Research Laboratories), Food and Drug Law Institute Conference on Clinical Trials, Washington, D.C., October 5, 1992. Also reported in Debrovner, D. 1993. Of mice and men. American Druggist January:30.

7.  

Department of Health and Human Services. 1983. 45CFR 46.116(b) (1); 21 CFR 50.25(b) (1).

8.  

Minkoff, H., Moreno, J., and Powderly, P. 1992. Fetal protection and women's access to clinical trials. Journal of Women's Health 1:37–41.

9.  

For their comments on an earlier draft, the author expresses his gratitude to his colleagues in the Division of Humanities in Medicine, and also to Howard Minkoff, M.D., and Richard H. Schwartz, M.D., all of the SUNY Health Science Center at Brooklyn.



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