FDA/Medicine
Hive @hive
started
FDA/Medicine
Hive @hive
I recently read a study about the fda in regards to its accuracy/testing on drugs when approving them.
Apparently around 1/3 of the current approved medicine has been found to have new safety risk.
Theres alot to dig into here but two highlights would be as follows for reasoning as into why they are having the issues, based on the study.
1. The data is being cherry picked for certain patients to give better results when approving medicine.
2. The size of the clinical trials is not sufficient nor are the follow up times long enough to spot out later problems.
Here is the link to the study.
http://jamanetwork.com/journals/jama/article-abstract/2625319
This has been a ongoing problem for some time. Especially with medicine being pushed out faster now.
What do you think about the FDA approval process?
What areas could be improved to ensure a more thorough screening process for approval of medicine?
dandaman @dantheman06
commented on
FDA/Medicine
dandaman @dantheman06
Well as you've said pretty much. EDIT: (Read that wrong, thought it said 222 days or something but Median is 4.2 years): Increase minimum sample size and give a requirement for at least 8 year's worth of data.
Not on any drugs now..hope not to be any time soon. Can't name all the cooked up lab stuff these days anyways.
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