ANDA guidances lack requirements to prove safety equivalence. The SAEs recorded during bioequivalence in a limited sample size does not adequately represent the real world use.
You will know that Kannan, given your vast clinical experience “in the real world”. It’s almost laughable that today’s regulators talk about real world data and real world evidence, but they don’t have any means of collecting it 🤔😳
I recently looked at the MSDS sheets for non-medicinal ingredients of supplements that I take and was astounded what was stated. I’m now a bit worried about taking them.
Great point Susan! Supplements go inside your body the same as drugs, so IMHO, they should be regulated, only not the way it works today. Regulation has been contaminated by Gates et al over 20+ years, to the point where it no longer exists. The only cure is jail got all the perpetrators…
ANDA guidances lack requirements to prove safety equivalence. The SAEs recorded during bioequivalence in a limited sample size does not adequately represent the real world use.
You will know that Kannan, given your vast clinical experience “in the real world”. It’s almost laughable that today’s regulators talk about real world data and real world evidence, but they don’t have any means of collecting it 🤔😳
Elon and Vivek need to establish a platform to channel federal employees who wish to speak up as Whistleblowers.
And to do that now.
Elon and Vivek may wish to inform the Whistleblowers that they have a generous number of positions available to those who come forward now:
Those who are committed to making America great again, to making America healthy again, and to making the federal government transparent again.
Spot on Thomas, as ever…
Let’s hope it gets up the ladder.
Sir.
I recently looked at the MSDS sheets for non-medicinal ingredients of supplements that I take and was astounded what was stated. I’m now a bit worried about taking them.
Great point Susan! Supplements go inside your body the same as drugs, so IMHO, they should be regulated, only not the way it works today. Regulation has been contaminated by Gates et al over 20+ years, to the point where it no longer exists. The only cure is jail got all the perpetrators…
A timely warning. Can we trust any drug these days. Consumption should probably be an absolute last resort.
Probably best not to trust any drug, Jas, sad to say…