4 ms·
It's a story about a drug company that is trying to unseat the current most popular sleeping drug. They went to the FDA process twice. At the end of the articl
by digitalzombie 9y ago
It's a story about a drug company that is trying to unseat the current most popular sleeping drug.
They went to the FDA process twice. At the end of the article the FDA is only approving 10mm dosage of the drug which is just as effective as placebo and that if the patient get no effect then doctor can prescribe higher dosage.
The drug company wants to go back and get approve at the higher starting dosage because starting at 10mm is stupid and would make user think their drug is ineffective.
I actually like the story, I just interned from FDA and am taking survival analysis right now and it's pretty nice to get a clear view of everything and history of sleeping drug and the mindset of FDA and the Drug company.