3 ms·
The message needs to be honed. Subtitle of “More trials, not laxer standards” then gives an example of RBM where in-person site visits and comprehensive data v
by refurb 2y ago
The message needs to be honed.
Subtitle of “More trials, not laxer standards” then gives an example of RBM where in-person site visits and comprehensive data validation are replaced by digital “checks”.
Ok, so “laxer standards” it is!
The key is knows which standards can be more lax without jeopardizing patient safety.
But I agree with the idea of the FDA incentivizing sponsors to leverage cost and time saving technologies. They often won’t do it themselves (or at least not quickly), but the FDA is in an ideal position to incentivize it.