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raistthemage

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raistthemage

Re: None

Saturday, 08/10/2019 2:52:04 AM

Saturday, August 10, 2019 2:52:04 AM

Post# of 425638
Legal question...

Could the FDA's decision to extend the PDUFA date once granted be considered "arbritary and capricious" legally (it certainly was in the real sense) since they had plenty of time to schedule an Adcom in the normal timeframe and opted not to do so.

Would they be covered under Sovereign Immunity (which I think should be abolished for the FDA at this point) or not?
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