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Niklas Anzinger
@NiklasAnzinger
Founder & CEO of Infinita | Montana ETRB | Stranded Technologies Podcast
加入 July 2009
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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
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