Can A REMS Block A Generic? Thalomid Could Be Early Test
Executive SummaryCelgene's arguments against generics of Thalomid (thalidomide) offer another example of the potentially vast consequences of FDA's new safety powers: The firm is arguing that the complexity of its risk management plan precludes the approval of alternate versions of the product
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Can generic manufacturers use patented elements of a drug distribution plan? Will FDA accept an alternative REMS program? Will brand companies have to provide access to their products? As the number of brand products subject to REMS grows, so do the unanswered questions for generic firms.