The FDA doesn't understand what it's asking and keeps making changes because this is a revolution in medical practice.
And they're either plodding bureaucrats or compromised advisors in a conflict-of-interest-riddled agency.
I can't wait for the new FDA head to take up the appointment and start making the necessary changes.
Even the FDA has written a report about urgently needed reforms within and plenty of expert reports have also been written showing how it's impeding approval of technological innovation with valuable unmet patient needs the result.
https://jamanetwork.com/journals/jama/article-abstract/2758582
https://www.mercatus.org/system/files/thierer-fda-reform-models-ep-v1_0.pdf
There are plenty out there just google it.
Ann: 36-Month Results of Phase 3 Trial in Chronic Low Back Pain, page-152
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