ohm: Your post implies that Dr Makary's June state
Post# of 157598
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Posted On: 09/16/2025 4:28:37 PM
ohm: Your post implies that Dr Makary's June statement about the FDA's use of AI to facilitate faster clinical trial protocol and approval decisions means that, among FDA'a 18,000 employees, their sole function regarding protocols and approvals will be to stamp "approved" or "denied" on whatever AI spits out.
Well, I suppose that could happen, but here's another possibility. Maybe, Dr Makary has the crazy notion that there's typically a bit of minutiae among the the thousands of pages of information that drug companies must file to complete FDA protocol and approval applications. Consequently, maybe he thinks a few weeks or months of review time currently allocated to such minutiae might be significantly reduced if AI is programmed to verify that all the minutiae is in order, thus expediting and focusing the FDA staff's attention to the key elements of the review process.
Well, I suppose that could happen, but here's another possibility. Maybe, Dr Makary has the crazy notion that there's typically a bit of minutiae among the the thousands of pages of information that drug companies must file to complete FDA protocol and approval applications. Consequently, maybe he thinks a few weeks or months of review time currently allocated to such minutiae might be significantly reduced if AI is programmed to verify that all the minutiae is in order, thus expediting and focusing the FDA staff's attention to the key elements of the review process.
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