|
|
 |
|
|
|
|
48. Drug makers address financial concerns of reform. Pharm. Rep. p. 3, Jan. 1994. |
|
|
|
|
|
|
|
|
49. Pharmaceutical Manufacturers Association. Trends in U.S. Pharmaceutical Sales and R&D. 19901993 PMA Annual Survey Report, October 1993, p. 4, 7, 25. |
|
|
|
|
|
|
|
|
50. J. Wechsler. Who will pay for R&D? Appl. Clin. Trials 3: 18, 1994. |
|
|
|
|
|
|
|
|
51. K. I. Kaiten, M. Manocchia, M. Seibring, and L. Lasagna. The new drug approvals of 1990, 1991, and 1992: trends in drug development. J. Clin. Pharmacol. 34: 120, 1994. |
|
|
|
|
|
|
|
|
52. J. Drews. The impact of globalization on pharmaceutical research and development. Drug Info. J. 27: 1059, 1993. |
|
|
|
|
|
|
|
|
53. J. A. DiMasi. The cost of innovation in the pharmaceutical industry. J. Health Econ. 10: 107, 1991. |
|
|
|
|
|
|
|
|
54. The Wilkerson Group. Integrated Health Care: Pharmaceutical Company Roles in a Seamless System. Wilkerson Pub., New York, March 1995, p. 46, 59. |
|
|
|
|
|
|
|
|
55. E. Tanouye. Drug makers are expected to report modest results for the second quarter. The Wall Street J. p. A8, July 8, 1994. |
|
|
|
|
|
|
|
|
56. FDA doing good job at meeting user fee review time goals. FDC ReportsThe Pink Sheet 58: 11, January 22, 1996. |
|
|
|
|
|
|
|
|
57. G. L. Barkdoll and K. A. McEvoy. Predicting the payoff from earlier approvals. Pharm. Exec. p. 46, November 1987. |
|
|
|
|
|
|
|
|
58. T. Rucker. Public policy and drug costs: Legitimate and bastard options. J. Research Pharm. Economics 4: 3, 1992. |
|
|
|
|
|
|
|
|
59. Wechsler. Politics and cost-effectiveness. Appl. Clin. Trials 4: 16, 1995. |
|
|
|
|
|
|
|
|
60. PHS/NIH Terminate Reasonable Pricing Clause. FDC ReportsThe Pink Sheet, p. 23, April 17, 1994. |
|
|
|
|
|
|
|
|
61. T. Culbert and P. Saint-Antoine. Justice Department premieres its guidelines for the licensing and acquisition of intellectual property. The National Law J. p. B5, December 5, 1994. |
|
|
|
|
|
|
|
|
62. 60 Fed. Reg. 20195 (April 25, 1995). |
|
|
|
|
|
|
|
|
63. R. Rines and S. Kaltenheuser. Proposed patent laws would harm inventors. The National Law J. p. A23, November 24, 1994. |
|
|
|
|
|
|
|
|
64. S. Schondelmeyer. Economic Impact of GATT Patent Extensions on Currently Marketed Drugs. PRIME Institute, March 1995. |
|
|
|
|
|
|
|
|
65. FDA GATT Policy Prevents Generic Approvals During Extensions. FDC ReportsThe Pink Sheet, p. 3, May 29, 1995. |
|
|
|
|
|
|
|
|
66. United States General Accounting Office. Prescription Drugs. Companies Typically Charge More in the United States Than in Canada. GAO/T-HRD-93-5, February 22, 1993. |
|
|
|
|
|
|
|
|
67. Drug Pricing Lawsuits. Rx Ipsa Loquitur 22: 3, 1995. |
|
|
|
|
|
|
|
|
68. Data on File FDA's Office of Orphan Product Development, Bethesda, MD, December 1994. |
|
|
|
|
|
|
|
|
69. Orphan Drugs with Sales Under Threshold Would Be Guaranteed Full Seven Years of Exclusivity Under Revision to Orphan Drug Amendments Proposed by HHS. FDC ReportsThe Pink Sheet 56: 7, June 20, 1994. |
|
|
|
|
|
|
|
|
70. AIDS Research Maximization Would be Aided by Permanent Restructured R&D and Orphan Drug Tax Credits. BIO Tells National Task Force on AIDS Subcommittee. FDC ReportsThe Pink Sheet 57: 45, May 1, 1995. |
|
|
|
|
|