She does a credible job of discussing w/open mind the kinds of issues we have reviewed here. Takeawys:
. FDA admits they have a problem and that their development processes are unsustainable and unresponsive. . FDA is looking for some way to fill the middle ground on providing evidence paths for drug development. (HEY...look at the AVXL Consortium) . FDA need to look at evidence based science which is timely and functional. (see Precision Medicine-too bad Dr.G. got no where fighting the political-FDA system) . FDA need to establish a patient-sponsor system that is both responsive and effective.
There is more also. We have stated here before that the first step in solving a problem is to recognize that one exists. Looks like they are finally doing that. Now we will witness if they are capable of doing what any manager worth their pay in the private sector would do. FIX IT NOW.
The FDA looks like it’s showing 2 sides. Once again we see leadership espousing forward thinking progressive plans, the boots on the ground are hunkered down in their trenches ready to thwart any advances by the enemy.
There’s trouble in Mudville.
Will Janet W. be the next victim of speaking out against the system?
Dr. G. on a beach in Bermuda, Janet checking if there’s any flights available. Just in case.
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