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Re: EIT post# 64065

Tuesday, 12/12/2017 5:58:38 AM

Tuesday, December 12, 2017 5:58:38 AM

Post# of 140474
Gottleib is a Trump appointee which signals he was put there to make things run more efficiently. This is exident by his new approach which should be GREAT news for SPORT!...

But imagine the benefits of a more efficient and transparent pathway for bringing to market well-understood technologies



This approach will be outlined in a new draft guidance that relates to the acceptable levels of uncertainty that FDA can accommodate in the pre-market setting relative to the public health benefits, and in turn rely on post-market data to answer certain questions.