Thanks for explaining US Code of Federal Regulations, Title 21. It’s very clear these products should have been withdrawn back in 2021/22 per FDA inspections. There are many substacks describing batch variability and contamination but I think you might be the only individual, correct me if I’m wrong, explaining FDA regulations for biologics and the complexity in manufacturing gene therapies as well as the inspection issues and 483s for BioNTech and Moderna. Do you have information on more recent inspections for 23/24? It would be interesting to see if there has been any improvement although I think that would be unlikely. Thanks again Hedley for the post!
Thanks Alison and yes, I am the only one with this level of understanding. Much of my career was in FDA regulated markets and I got to know many of the senior staff personally when I co-chaired the Global Outsourcing Conference at Xavier University in Cincinnati from 2010 - 2013. Think I’m getting some traction now, but it has been hard going to get much attention in al the ‘noise’ over the last four years 🙏👍
I hope Ron Johnson invites you to Washington to attend his senate hearings. CFR 21 should be the main topic of discussion and implementing steps to withdraw the mRNA platform. Medical Doctors for Covid Ethics just had an interesting discussion with Sucharit Bhakdi 2 weeks ago. Apparently there is a whistleblower from the RKI who is stating Covid is a crime, not a lab leak, and they have extensive documentation to support this. Senator Ron Johnson attended this panel as well.
Hopefully this information will help your message gain traction. Honestly, I think 50 percent of America does not buy into the lab leak theory any longer, myself included, so timing might be perfect for next year.
Thanks Alison, that's very heartening. I should say that I managed to get on a Zoom call with Senator Johnson about 2 years ago. My pitch was going to be that the PREP Act could not supersede the Federal Food, Drug and Cosmetics Act of 1938, established to keep patients safe, and the subsequent code of federal regulations title 21 - the regulations FDA has to exercise its powers in keeping patients safe. Unfortunately, there was another substack writer on the call with a 50 minute presentation that took up the whole of the session, covering topic I believe to be irrelevant and diversionary - but I'm still going :O)!!!
Yes, I think I know who you are referring to. I was mislead into following this individual initially but thanks to you and others have a better understanding regarding FDA regulations. Jeff Childers, attorney in Florida, is challenging the Prep Act. Childers complaint is about Prep violating the Constitution’s separation of powers because it undermines the judicial branch of gov. I am not an attorney and this seems to be an excellent case however your position that Prep can’t supersede Federal Food Drug and Cosmetics Act seems even more relevant. I hope Senator Johnson takes a closer look at what you have to say as it is extremely urgent to get these products off the market.
Thanks for explaining US Code of Federal Regulations, Title 21. It’s very clear these products should have been withdrawn back in 2021/22 per FDA inspections. There are many substacks describing batch variability and contamination but I think you might be the only individual, correct me if I’m wrong, explaining FDA regulations for biologics and the complexity in manufacturing gene therapies as well as the inspection issues and 483s for BioNTech and Moderna. Do you have information on more recent inspections for 23/24? It would be interesting to see if there has been any improvement although I think that would be unlikely. Thanks again Hedley for the post!
Thanks Alison and yes, I am the only one with this level of understanding. Much of my career was in FDA regulated markets and I got to know many of the senior staff personally when I co-chaired the Global Outsourcing Conference at Xavier University in Cincinnati from 2010 - 2013. Think I’m getting some traction now, but it has been hard going to get much attention in al the ‘noise’ over the last four years 🙏👍
I hope Ron Johnson invites you to Washington to attend his senate hearings. CFR 21 should be the main topic of discussion and implementing steps to withdraw the mRNA platform. Medical Doctors for Covid Ethics just had an interesting discussion with Sucharit Bhakdi 2 weeks ago. Apparently there is a whistleblower from the RKI who is stating Covid is a crime, not a lab leak, and they have extensive documentation to support this. Senator Ron Johnson attended this panel as well.
Hopefully this information will help your message gain traction. Honestly, I think 50 percent of America does not buy into the lab leak theory any longer, myself included, so timing might be perfect for next year.
Thanks Alison, that's very heartening. I should say that I managed to get on a Zoom call with Senator Johnson about 2 years ago. My pitch was going to be that the PREP Act could not supersede the Federal Food, Drug and Cosmetics Act of 1938, established to keep patients safe, and the subsequent code of federal regulations title 21 - the regulations FDA has to exercise its powers in keeping patients safe. Unfortunately, there was another substack writer on the call with a 50 minute presentation that took up the whole of the session, covering topic I believe to be irrelevant and diversionary - but I'm still going :O)!!!
Yes, I think I know who you are referring to. I was mislead into following this individual initially but thanks to you and others have a better understanding regarding FDA regulations. Jeff Childers, attorney in Florida, is challenging the Prep Act. Childers complaint is about Prep violating the Constitution’s separation of powers because it undermines the judicial branch of gov. I am not an attorney and this seems to be an excellent case however your position that Prep can’t supersede Federal Food Drug and Cosmetics Act seems even more relevant. I hope Senator Johnson takes a closer look at what you have to say as it is extremely urgent to get these products off the market.
You can have mine.
nothing like 'warp speeding' death & disease on the populace...
Thanks Hedley. The greed for profit clearly dismisses safety regulations as an unecessay hurdle
Exactly Jas - Bill Gates saw the opportunity and the rest is history…
.
The Best Part Of A Psy-Op
Is When They Argue About
Natural Origin vs. Lab Leak.
When Their Wasn’t An Airborne
Pathogen That Even Existed.
Now That’s Gain Of Function.
.
Very true Thomas!