There’s a couple of interesting things happening inside of all of that change of process.
Bulk scientific studies, thousand page complex documents, and entire submissions, get scanned and synthesised prior to the reviewer assessment. Days of intense analytical work, get reduced to several seconds. Vast increase in speed.
The specificity of individual specialist silo reviewers, gets amalgamated into a whole of submission analysis. Less precise perhaps, perhaps not, but gives them a broader, more holistic understanding of the documentation in front of them. Fewer human checkbox roadblocks and fewer multiple internal review processes.
In the specific case of a plausible mechanism pathway for rare diseases, the old risk threshold has been (not entirely) replaced with a patient-centric risk management approach, acknowledging the patient perspectives and preferences when faced with a life-threatening disease. Recognises that patients with rare diseases have unique needs and risk tolerances that should be considered during drug development and approval processes, rather than relying solely on traditional clinical trial data.
Added to that, is a much greater emphasis on post-treatment follow-up, that incorporates more accurate scrutiny via access to all, not-previously-available health databases, and an AI analysis of those results as well. Real world data used as a phase IV trial.
This is current and relevant - no reason to think it’s not being applied right now to backlogged applications.
FDA is currently begging for new reviewers and other staff, and Elsa is working in the background 24 seven.
Tools to self assess applications in advance— great idea!!
Ice
(20min delay)