Technological Innovation Comparing Development of Drugs, Devices, and Procedures in Medicine, Background Paper (1989) / Chapter Skim
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Appendix
Appendix
Pages 53-54
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indicate that, not only were there changes over time in the numbers of INDs filed, but also in the pharmacological types of NCEs entering human testing. If one compares the mid 1960s with the early 1980s, for example, the number of antiinfective and psychopharmacological drugs decreased markedly, while cardiovascular drugs initially decreased somewhat and then increased again, and antineoplastic and gastro-intestinal drugs increased steadily2.
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From page 54... ...
, he asserts that "the thalidomide tragedy was the proximate cause in the decline, acting quickly through its effects on the direction of drug industry research and more slowly through the governmental regulatory process". Tn short this literature does not specify the exact effect of changing regulatory requirements on the decline, it does demonstrate that regulatory requirements are an important factor in determining how, and whether, a drug is developed.
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