Find a way to accelerate the discovery/resolution process.
Many of us have experience working directly with regulatory bodies in resolving technical problems. Generally such bodies resist change of just about any kind. Changes often involve some level of risk management even rewriting the book of rules/guidance docs. No one wants to put their name on risky things or even be in the room when that discussion happens, never mind be the fool driving for change...they are ...."toe-less wonders".
We recognize that FDA top management are risk averse , they need to turn this into a strength ASAP. Other industries have done this. The MED-PHARMA -FDA need stop relying on statistical models to cover their AXXS and fix the science instead. They can begin by sitting in a room w/people like dr.M. and JUST LISTEN..
Too many innocent people have suffered and died already. Statistical models are being used to cover people's axxes. At this rate, we will all be dead before these guys get it.
I once helped a very brave & smart regulatory leader drive change which accelerated the rate at which highly complex semiconductor devices failed in military and commercial , space flight applications. The bio-physics were on the same level of complexity as these CNS-Bio-Pharma products and the consequences of failure were literally nuclear. If we look closely enough we will find other such examples in industry everywhere. Risk analysis/diagnosis tools-methods are how progress is made. Change is not a subject to turn away from when it is as obvious as this entire CNS regulatory body of work demonstrates.
First, Find a way to accelerate the RATE of failure in the LAB and then develop methods/science/techniques needed reduce/eliminate that root cause. Then prove effectiveness through zero risk application once the model is implemented through careful development of root cause analysis and then effective preventative techniques. (SEE Rome Air defense Center , RADC) development of HTRB as a mechanism to induce/cause failures in complex semiconductor devices and fire control and comm. systems.
