Partly good news for accelerating phase-1 trials, by new FDA appointees:
- Reduced requirements for "QRIs" (supposed to be the equivalent of Australia's ethics boards whose approval is mostly accepted as "go ahead" for phase-1 trials)
- FDA only wants a pilot program with 10 companies, and not give away any authority (which Australia doesn't either, it just sets a culture of trust in their boards).
That leaves is partly open to how it will be done in practice how successful it will be.
I still think it's not enough: Australia has done it successfully for 30+ years. Just skip the pilot, move right to accepting applications, helping the initial QRIs get it right so it's easy for you to say yes, publish success rates of QRI-to-phase-1 acceptance
@endpts @maxonwifi @houmanhemmati