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 that scientific evidence supporting an NDA be published.
 This stems from the fact that a consensus of experts outside
 FDA is not required for NDA approval_ In contrast, most
 courts have held that a drug cannot be considered GRASE
 unless the supporting scientific evidence appears in the
 published scientific and medical literature. Without
 published studies, it would be difficult for the community
 of experts outside FDA to develop an informed acceptance of
 a drug for medical useo Coo_____s Inco v. FDA, 501 Fo2d
 772, 786 (D.C. Cir. 1974).
 Point four of the eight-point test focuses, in part, on
 the '_general availability of info_nation regarding the
 substance and its useo _' This should be clarified to read:
 In the absence of NDA approvalp information
 concerning the chemistry_ pharmacology, toxicology
 and effectiveness of the substance must be
 reported, published, or othe_¢ise widely
 available, in sufficient detail to permit experts,
 qualified by scientific training and experience to
 evaluate the safety and effectiveness of drugs, to
 fairly and responsibly conclude the substance is
 safe and effective for use in treating a specific,
 recognized disorder.
 F. General Availabilit of a Q__q__i_____rrelevanto
 The second component of point four of the eight-point
 test involves the _generai availability of the substance"
 for use in treatment. The second component of point eight
 focuses on 'ruse of the substance by a substantial segment of
 the medical practitioners in the United Stateso _ These
 elements justifiably concerned the Court of Appeals, leading
 to the remand in this case°

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