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Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-258

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    Re your post " That document doesn't answer Blackkkkk's questions. "

    I don't know why a poster would say that. Which questions are you talking about?

    'That document', as you refer to it, certainly answers most of mine. Has @Blackkkkkkk read it in full? Have you read it in full? And have you also read the other documents referenced in it?

    For example, this one which I find very helpful: https://www.fda.gov/media/85659/download

    These SOPPs are intended by the FDA to work together. For example, have a look at this:

    https://hotcopper.com.au/data/attachments/6026/6026645-56c10b7971b125f34b77e6f54cd38de8.jpg
    Let me know which of these provisions you find irrelevant.

    GLTAH
 
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