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Effective:
Effective:
Under the Kefauver-Harris Drug Amendments of 1962 (amending the Food, Drug, and Cosmetic Act of 1938), a drug is considered to be effective that has been designated as such by the Food and Drug Administration on the basis of "substantial evidence." Such evidence was defined by Congress as "... adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved."
Cf. Food and Drug Administration, U.S.P.
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