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Re: Steady_T post# 400319

Saturday, 01/28/2023 9:54:57 AM

Saturday, January 28, 2023 9:54:57 AM

Post# of 462742
Staedy_T...

Grasp the concept. The FDA does not tell industry what to research. At best the NIH provides funding for specific research areas. Industry decides where they want to spend research money on.



Trust ME: We get it. The existing process does not work, it has not been effectively implemented, in the case of AD. This can happen for a number of possible reasons, including systemic corruption, incompetence or arrogance which blocks all alternative thoughts and plans. Eventually (after the real solution/system/structure is established) those in charge will look back in wonder at just how poorly the system functioned. I am very familiar with how the FDA is set up and functions. In fact the rules are already in place to fix it. You might study them. I suggest you begin by studying the meaning of the terms the FDA often uses...to include...definition of a system, the meaning of the term EFFECTIVE(in this context) , implementation of an EFFECTIVE CORRECTIVE AND PREVENTIVE ACTION SYSTEM. These are just the beginning of what I would write in a list of FINDINGS if I conducted an AUDIT of the current management system. Suggest you get focused on the COMPLIANCE REQUIRED TERMS , for example ...PREVENTION -CORRECTION-MANAGEMENT RESPONSIBILITY
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