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

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:


Let me know which of these provisions you find irrelevant.

GLTAH