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Re: polarbear77 post# 140051

Wednesday, 02/07/2018 7:34:22 AM

Wednesday, February 07, 2018 7:34:22 AM

Post# of 461425
Bear...I love this kind of talk. Way overdue. Puts a lot of pressure up front. from FDA...

• Explore the development of a policy framework under which an accelerated approval approach could be used to support marketing of a drug that demonstrates a survival benefit early in clinical development. The goal is to expedite availability of a therapy while the magnitude of the benefit it provides is being confirmed
Advance the use of new drug development tools and mobile technology for better capturing clinical trial data and the measurement of safety and benefit in pre- and post-market settings”

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