Flimsy Evidence Behind Many FDA Approvals
Flimsy Evidence Behind Many FDA Approvals - Hallo World !!! News Today in World, In this article you read by title Flimsy Evidence Behind Many FDA Approvals, We've prepared this article well so you can read and retrieve information on it. Hopefully the contents of the post
Article Salisbury News, What we write can you understand. Okay, happy reading.
Title : Flimsy Evidence Behind Many FDA Approvals
link : Flimsy Evidence Behind Many FDA Approvals
You are now reading the article Flimsy Evidence Behind Many FDA Approvals With link address https://newstoday-ok.blogspot.com/2017/08/flimsy-evidence-behind-many-fda.html
Title : Flimsy Evidence Behind Many FDA Approvals
link : Flimsy Evidence Behind Many FDA Approvals
news-today.world | Many drugs granted accelerated approval by the U.S. Food and Drug Administration (FDA) lack clear evidence of safety and effectiveness, and the same is true for most high-risk medical devices, according to two new reports in the Journal of the American Medical Association.
The Accelerated Approval pathway makes potentially promising investigational medicines available for use before the usual amount of data has been collected to confirm their effectiveness and safety, Dr. Huseyin Naci from the London School of Economics and Political Science told Reuters Health by email.
“Drugs granted Accelerated Approval should be rigorously evaluated using convincing patient-centered clinical outcomes in rigorous studies,” Naci said. But, he added, “we have found numerous situations in which required confirmatory studies with rigorous designs and outcomes are not pursued or are not completed in a timely fashion, and in these cases, we are concerned that regulators appear to accept data that would not otherwise meet FDA standards.”
More here
The Accelerated Approval pathway makes potentially promising investigational medicines available for use before the usual amount of data has been collected to confirm their effectiveness and safety, Dr. Huseyin Naci from the London School of Economics and Political Science told Reuters Health by email.
“Drugs granted Accelerated Approval should be rigorously evaluated using convincing patient-centered clinical outcomes in rigorous studies,” Naci said. But, he added, “we have found numerous situations in which required confirmatory studies with rigorous designs and outcomes are not pursued or are not completed in a timely fashion, and in these cases, we are concerned that regulators appear to accept data that would not otherwise meet FDA standards.”
More here
That's an article Flimsy Evidence Behind Many FDA Approvals
Fine for article Flimsy Evidence Behind Many FDA Approvals This time, hopefully can benefit for you all. Well, see you in other article postings.
You are now reading the article Flimsy Evidence Behind Many FDA Approvals With link address https://newstoday-ok.blogspot.com/2017/08/flimsy-evidence-behind-many-fda.html