👍
Btw, one reason this approval went fast is because Roche has good reputation given body of work.
This suggests an alternate regulatory paradigm: clear the company, not every drug/device.
Similar to how CLIA works, where a lab is cleared and then can roll out new tests.
Btw, one reason this approval went fast is because Roche has good reputation given body of work.
This suggests an alternate regulatory paradigm: clear the company, not every drug/device.
Similar to how CLIA works, where a lab is cleared and then can roll out new tests.
That clearance would need to be maintained, but it works for labs.
Normally, a CLIA lab director can roll out a new laboratory developed test without submitting it for “pre-market review”.
In this emergency, FDA CDRH gained ability to bottleneck this normally fast process.
Normally, a CLIA lab director can roll out a new laboratory developed test without submitting it for “pre-market review”.
In this emergency, FDA CDRH gained ability to bottleneck this normally fast process.
One secret of regulatory review is that it’s not fully based on rule-of-law or even science.
A huge part of it is the *reputation* of applicant in regulator’s eyes, as well as regulator’s rep with public.
This book is “pro FDA” but discusses this thesis.
press.princeton.edu/books/paperbac…
A huge part of it is the *reputation* of applicant in regulator’s eyes, as well as regulator’s rep with public.
This book is “pro FDA” but discusses this thesis.
press.princeton.edu/books/paperbac…
