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Re: williamssc post# 207085

Sunday, 08/25/2019 8:33:26 AM

Sunday, August 25, 2019 8:33:26 AM

Post# of 470850
Only an organization like the FDA can get away with a statement like this.

Accelerated Approval or priority review if the requisite criteria are met. Accelerated approval is meant for drugs that demonstrate an effect on a surrogate, or intermediate endpoint reasonably likely to predict clinical benefit. Priority review shortens the FDA review process for a new drug from ten months to six months, and is appropriate for drugs that demonstrate significant improvements in both safety and effectiveness of an existing therapy. A fast track application is automatically considered for both of these designations.

-thanks for link Williamsc

https://en.wikipedia.org/wiki/Fast_track_(FDA

How about connecting to the real world where people are passing daily. At least get a clock synched up w/human costs and benefits.

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