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Emergency Use Authorisation isn't the best pathway because...

Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #
  1. Mcfisty
    275 Posts.
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    31/07/20
    18:04
    Post #: 46226139
    Emergency Use Authorisation isn't the best pathway because approval is only valid for duration of emergency and may not allow for expansions of product. De Novo submission is likely still the only viable pathway, however I know for a fact that FDA is prioritising devices applicable to covid.
    RAP Price at posting: 14.0¢ Sentiment: Hold Disclosure: Held
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    lightbulb Created with Sketch.  Great analysis
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