“And I would argue that in a time of rapidly emerging biology, when we've got more and more scientific innovations and potential products coming to bear, The need to make sure that we have an objective way of assessing safety and effectiveness and providing consumer confidence that this treatment is appropriate for me is a responsibility FDA that actually has more responsibility, not less.”
quote is from the automated transcript, cleaned for reading:
filler sounds and stutters are removed, nothing is rephrased. names can be misheard
(the analysis reads context, assessments check outside sources). how →
More from FDA Chief Information Officer
AssertionNot checkable as stated
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“Can we come up with, essentially, preconditions for software updates? So that if there are strong quality controls in the way software is developed, well understood product performance as an expect, in terms of the expectation updates, can you now have algorit…”
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