Vioform HC DESI hearing
FDA's Center for Drugs and Biologics has requested the Administrative Law Judge to deny Ciba-Geigy's motion to require FDA to provide a list of upgraded DESI drugs that were classified as effective on any basis other than two adequate and well-controlled studies.The Center maintains the "'two study' question is an issue of law and not one of fact susceptible to proof with evidence in the form of data and other scientific information"
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