“It’s good that the FDA lifted the ban on Bexsero but why should Americans have to wait for the FDA?” [Alex Tabarrok, Bloomberg]
“It’s good that the FDA lifted the ban on Bexsero but why should Americans have to wait for the FDA?” [Alex Tabarrok, Bloomberg]
5 Comments
It’s even worse than that. The FDA wont even consider clinical trial data collected in Europe and published in peer review journals.
Does the FDA need enabling legislation to allow this kind of rule change, or do we need legislation to force them to change the rules?
And now the FDA is threatening Diamond Nuts because it’s saying that based on Diamond’s marketing about healthy Omega-3s in walnuts, that walnuts are a drug and Diamond must file a new drug application.
Didn’t they try this with Cheerios too, with the heart healthy marketing they were doing?
The letter at FDAs site.
Thanks for the link, Kimsch. Is hubris a psychological malady?
Bob