GK...thanks for your thoughts on FT(D)A. IMO, somewhere over the past 30 years or so the FDA lost it's way. As we know around the late 80's they rewrote a lot of their internal compliance and guidance procedures. They morphed from stopping snake oil sales to emphasis on "Safe and Effective". Which if you think about it, is a pretty broad scope. Bottom line IMO their mission probably literally cannot be done. It is time for them to ether fish or cut bait.
How safe is safe? How the hell do they plan to ensure everything is always safe? Well, it ain't and cannot be unless there is nothing coming out. They prove this with every recall and new warning label. (fish or cut bait)
What does effective REALLY MEAN anyways. Is it ALWAYS effective and what does that mean? Forever? I know, put expiration times on the label to.
IMO, the FDA is a massive organization w/a lot of good smart people who literally have a job descriptions which cannot be done. That is a leadership problem that has morphed into a BP/Insurance co./political/WS/everyone's problem/Bad Joke.
Precision medicine is conceptually a step in the right direction but they have to lose the (all things to all people) headset and define the science better. They need to start with..."If we cannot measure it, we cannot control/fix it"...everyone go back and find/get agreement on how to measure CNS diseases(all of them) and then come back so we can evaluate proposals. And, get everyone to agree on how to measure/control your solution. The FDA is not structured to fix all the worlds problems, all we do is regulate. It is management 101.
Also, PLEASE GIVE ME A LIMIT OF at least 10 on my IHUB IGNORE buffer....PPPPLLLLLLEEEEEEAAASSSSE.
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