FDA’s Disparate Treatment Of Fibrinogen Products ‘Defies Logic,’ Octapharma Contends
Suit says FDA wrongly classified the fibrinogen products of three blood centers as ‘blood components’ exempt from clinical trials while classifying Octapharma’s Fibryga as a ‘blood derivative’ subject to clinical studies.
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Merger reviews could take into account sponsor's Orange Book behavior. FTC's statement does not detail what would make a patent listing 'improper' but the precedents from court cases against various sponsors should offer industry some guideposts.