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Drug Development, Guidelines, and the Food and Drug Administration

SANFORD H. ROTH, M.D.; and ALLEN MACKENZIE, M.D.
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St. Luke's HospitalPhoenix, ArizonaCleveland Clinic Foundation; Cleveland, Ohio


Ann Intern Med. 1984;101(1):125-127. doi:10.7326/0003-4819-101-1-125
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The costs of arthritis to society are climbing to an estimated $13.5 billion per year (1). Furthermore, drug development has slowed while the expense of such development has skyrocketed during the last 22 years. In 1962, 46 new drugs—each costing $2 million to research, test, and approve over a mean 2-year development period—were introduced to the market in the United States. In contrast, during 1980, only 17 new drugs were introduced at a mean cost of —70 million per drug, with each drug requiring a 10-year development period. Thus it now costs 35 times as much and takes 5 times

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