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OF course you don't hear Missling complain about

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nidan7500   Monday, 10/21/19 02:45:11 AM
Re: Steady_T post# 215461
Post # of 230990 
Quote:
OF course you don't hear Missling complain about the FDA. That would be seriously stupid thing to do.

Thou shalt not piss off the regulators lest thee become mired in endless bureaucracy.



Only those w/a death wish will openly criticize the FDA policy and practice. But, that's not the problem. The real problem is that the FDA does not critique or evaluate itself (in a meaningful way) either. Only those crusaders (like Dr.G.) have been effective at making REAL CHANGES to FDA dogma, and then he had to get out of town.

Has anyone ever seen any serious study or publication on how the FDA processes have failed to develop or to support the development of AD or other CNS diseases, for example? Would anyone dare suggest the FDA has failed to accomplish it's mission (after > 50 years) in CNS disease treatments. The obvious point is there is no effective structure or process w/in the FDA for self examination or process critique. Can anyone in the FDA explain how the Amyloid Thesis survived many multiple examples failures (NADA/ZILTCH/ZERO) causal relation to AD. Yet, the Govt kept spending and no one was ever heard to say....this is obviously going no where, until Dr.G. pulled the process plug.

Private sector failures to deliver are self identifying. That is why we have CAPA processes. No one in the FDA leadership applied the same simple (5 why's) kind of management responsibility to their own work. Hence we have a national crisis and no base system to correctly address it. Fixing the FDA is a suicide mission b/c it has to start with admitting a problem exists.

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