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20. J. N. Gibbs. FDA proposes new drug and biologic reporting requirements. Regulatory Affairs Professionals Society Newsletter. January 1995, p. 6.
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21. Did liability block AIDS trial? Science 257: 316, 1992.
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22. 59 Fed. Reg. 39406 (July 22, 1993).
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23. U.S. FDA alters rules on women in clinical trials. SCRIP 1845: 15, August 10, 1993.
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24. Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Revision of Pediatric Use Subsection in the Labeling, 21 CFR Part 201. Docket No. 92N-0165.
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26. Havner v Merrell Dow Pharmaceuticals Inc. 88-3915-F (Dist. Ct., Nueces Co., Texas), March 17, 1994.
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27. $19.2 million verdict against Marion Merrell. National Law J. p. B2, July 4, 1994.
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28. Racketeer Influenced and Corrupt Organization Act. P.L. 91452, Sec. 1, 84 Stat. 22 (1970).
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29. Upjohn v Oswald, 1992U-111 (High Ct.) England.
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30. DHHS Federal Tort Claim 93-M-186.
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31. A. Blum, HalcionR stirs litigation storm. National Law J. p. A1,A23, April 11, 1994.
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32. Strain of Norplant's High Up-front Costs Has Subsided. U.S. General Accounting Office, HEHS-95-7, October 1994.
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37. PhRMA Data. 1995.
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39. M. M. Rumore. Issues on vaccines. Amer. Pharm. 32: 7, 1992.
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40. Childhood Vaccine Injury Act. P.L. 99660 (1986).
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41. R. P. Charron. An AIDS vaccine: It may take an Act of Congress. J. NIH Research 6: 84, 1994.
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42. Farnes v E.R. Squibb & Sons, 92-10250-CA-01 (Cir. Ct., Monroe Co., FL.).
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43. M. M. Rumore and S. Strauss. Pharmacoepidemiology: regulatory role of the pharmacist. New York State J. Pharm. 11: 42, 1991.
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44. H. Berkman. Showdown in Senate on Tort Reform. The National Law J. p. A1, A26, May 1, 1995.
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46. D. Barker. The effects of tort reform on medical malpractice insurance markets: an empirical analysis. J. Health Politics, Policy and Law 17: 143, 1992.
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47. W. Griffen. Reforming medical device liability. Medical Device & Diagnostic Industry, p. 110, May 1994.

 
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