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be efficacious as well as safe, was made part of US law. The DESI program was intended to classify all pre-1962 drugs that were already on the market as either effective, ineffective, or needing further study. The Drug
Efficacy Study Implementation (DESI) evaluated over 3,000 separate products and
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over 16,000 therapeutic claims. By 1984, final action had been completed on 3,443 products; of these, 2,225 were found to be effective, 1,051 were found not effective, and 167 were pending.
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Chhabra R, Kremzner ME, Kiliany BJ. FDA policy on unapproved drug products: past, present, and future. Ann
Pharmacother. 2005 Jul-Aug;39(7-8):1260-4.
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FDA aims to remove unapproved drugs from market: Risk-based enforcement program focuses on removing potentially harmful products
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The Drug
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One of the early effects of the DESI study was the development of the
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United States
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