1. Pink Sheet

EpiPen Generics: Woodcock Explains Injector Studies

 
• By Derrick Gingery

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.

EpiPen

For potential EpiPen competitors, it appears FDA's requirements to fix problems with the device may not be extensive.

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