Insurance coverage is something PPHM should verify in vetting CSM before the contract was awarded.
I would have to disagree, if it makes the FDA qualified list of CRO's... wouldn't the FDA be responsible for that?
If it was ever a small biotechs responsibility to investigate a CRO, why would the FDA set up a qualified list to choose from? and I would think "any" protocol that could jeopardize patients due to mishaps should be written in the FDA protocol that makes it a requirement for a small biotech to investigate CRO's they pick off the FDA qualified list. (ok, will admit being sarcastic on that last remark)
Maybe we should all consider if the FDA has an insurance policy if they are the ones allowing some past practices to continue for much too long? I'm sure Peregrine can pin point them in the right Fargo direction. Does the FDA ever pay out?
Yes... its called approving a drug that should have been approved in the first place and working for its proper FDA approval
Bavituximab comes to mind
The FDA has been sued many times but I don't see any record of them paying out.... who knows what is going on behind the iron curtains
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