Under the DESI program, the FDA contracted with which organization to evaluate older drugs approved between 1938 and 1962?

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Prepare for the Stewart Self Care and Legal Test. Flashcards and multiple choice questions enhance your study experience, complete with hints and explanations. Ace your test confidently!

Multiple Choice

Under the DESI program, the FDA contracted with which organization to evaluate older drugs approved between 1938 and 1962?

Under DESI, the FDA turned to the National Academy of Sciences/National Research Council to conduct a comprehensive evaluation of older drugs approved between 1938 and 1962. This body was chosen because it could assemble independent expert committees and apply rigorous scientific judgment to historical data, in line with the tightened efficacy standards established after the 1962 Kefauver-Harris amendments. The other organizations—NIH, CDC, and the World Health Organization—do not fit the role of an independent review body contracted to reassess efficacy for these legacy drugs, which is why NAS/NRC is the best fit for this program.

Under the DESI program, the FDA contracted with which organization to evaluate older drugs approved between 1938 and 1962?

Prepare for the Stewart Self Care and Legal Test. Flashcards and multiple choice questions enhance your study experience, complete with hints and explanations. Ace your test confidently!

Under the DESI program, the FDA contracted with which organization to evaluate older drugs approved between 1938 and 1962?

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