Schering Corporation vs. Food and Drug Administration

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Schering Corporation vs. Food and Drug Administration

Schering Corporation vs. Food and Drug Administration

ANSWER


The legal affair team of Schering Corporation led by the Joseph C. condor et al sued the food and drug administration for unfair granting of licenses to manufacture of generic drugs.  While the Schering Corporation carries out research on drug manufacture As well as distributes its manufactured drug products, they think that food and drug administration has applied wrongly the regulatory methods of drug manufacture and distribution particularly concerning generic drugs. According to the Schering corporation, they raise the argument on the exclusively rule(s) which are applied in the approval of generic drugs. The issue is whether there is a single exclusive rule which must apply in the determination of generic drug.  The Schering Corporation believes that bioequivalent requirements established in section 355 (j) (B) must be an exclusive regulatory procedure that determines the validity of generic drugs to be manufactured and distributed within the states (OpenJurist.org, 2010).