For potential EpiPen competitors, it appears FDA's requirements to fix problems with the device may not be extensive.
Center for Drug Evaluation and Research Director Janet Woodcock outlined to Senators Sept. 21 the potential steps that could be...
EpiPen Generics: Woodcock Explains Injector Studies
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In response to Congressional questions about whether FDA is a barrier to competition for the epinephrine product, CDER Director lays out what could be required to prove an injector device problem is fixed.
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