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 i one schedule to another. See 21 U_S°C. 81!(c) (2) , (3) (1988).
 l Insofar as these factors relate to the determinative finding of
 whether or not a drug has a _'currently accepted medical use," the
 I Administrator's consideration of information relevant to the
 FDA's determination of a drug's safety and efficacy is
 I undoubtedly reasonable. Both statutes call upon the government
 to determine what purpose a given drug is supposed to serve and
 whether the drug truly serves that purpose°
 l Since the FDA has refused to applications to
 introduce new drugs into interstate commerce (New Drug
 Application or NDA) when _there is a lack of substantial evidence
 i that the drug will have the effect it purports or is represented
 to have _' according to its proposed labeling° See Drug Amendments
 of 1962, tit. i_ § i02(c) _ 76 Stato 780_ 781 (1962) (current
 version at 21 U.S.C. 355(d) (1988)). Substantial evidence
 sufficient to support approval of the application consists of:
 adequate and well-controlled inw_stigations_ including
 clinical investigations_ by expe:[ts qualified by
 scientific training and experience to evaluate the
 effectiveness of the drug involved_ on the basis of which
 it could fairly and responsibly be concluded by such
 experts that the drug will have =he effect it purports or
 is represented to have [according to its proposed
 21 U.SoCo 355(d) (1988). The implementing regulations enumerate
 that "have been developed over a period of years
 and are recognized by the scientific community as the essentials
 I of an adequate and well-controlled clinical investigation." See
 21 C.F.Ro 314.126. _he controls and other characteristics listed
 support the investigationai objective of _'distinguishing the
 I 14

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