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Re: ORBAPU post# 395532

Tuesday, 12/13/2022 6:07:55 PM

Tuesday, December 13, 2022 6:07:55 PM

Post# of 426486
You're not understanding my point. The FDA is run by government employees. Whereas a Self regulating body is not, it's private sector. For example; In my usta line of work, Nuclear worker, we had the Nuclear Regulatory Commission (NRC US Government) and Institute of Nuclear Power Operations (INPO) which was funded by Electric Utility Companies. Although INPO was not the ultimate decision maker, it was staffed by Industry Experts (Subject Matter Experts) such as Engineers, ex-Nuclear Navy, Maintenance Journeyman who can provide quality oversight of Nukes in the USA. It is a "Peer" Organization who's charter it is to improve all aspects of Nuclear Operations and Performance.

The NRC allowed us to Build and Operate Power Plants (NRC License), but INPO added another dimension by conducting performance evaluations on all areas of the Power Plant such as Operations, Engineering, Maintenance and Training. The NRC had review authority over our processes, but INPO provided a deeper dive into those processes and made recommendations on how to improve on those processes.

My point being; the FDA has oversight on the Pharmaceutical Industry, but don't forget the FDA stands for the Food and Drug Administration. A tall order. They need help, as it appears to me IMHO there is no "Peer" (private sector) Organization that I helps to improve the Pharmaceutical Industry. Sure there's quasi groups perhaps IFPMA https://www.ifpma.org/ Who we are: IFPMA promotes sustainable solutions that encourage innovation and improve patients’ health around the world. Blah blah......Or there's the NCBI (National Center Biotechnology Information) https://www.ncbi.nlm.nih.gov/guide/#:~:text=The%20National%20Center%20for%20Biotechnology,Organization%20%7C

These groups say nothing about Peer evaluations. How are these organizations staffed? What kind of credentials and expertise do they provide?

That's all I'm saying, where does the rubber meet the road?
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