We let the experts express their opinions, some of whom are on stage today. And then we have our subject matter experts at the FDA do an incredible comprehensive review of the literature. The conclusion of that review was a recommendation to remove certain black box warnings. That recommendation was presented to me. I accepted it and that makes it final. So we are letting the public know now the companies will reprint and accept those label changes. (36:11–36:17)
CLAIM
Asserts that a review recommended removing certain black box warnings.
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