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To: nickcarraway
“Certainly the drug holds great promise for individuals struggling with opioid addiction. However, there's still a lot we don't know about its effectiveness”

So the FDA doesn't care about the effectiveness of Drugs they approve, whats up with that?

4 posted on 05/28/2016 2:56:18 AM PDT by DAC21
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To: DAC21
So the FDA doesn't care about the effectiveness of Drugs they approve, whats up with that?

The FDA cares a lot. Once a drug is approved, the FDA does not stop monitoring its safety and efficacy. The pharmaceutical companies are required to continue to work with the FDA in what is called a "phase 4 clinical trial," which is where the company still collects data on patients who are using the approved drug by prescription.

If the company wants to market the drug for a slightly different purpose than it was approved for, the company has to do clinical trials in support of the altered use. For example, the approved implant delivers 8 mg of the drug per day. But if the company wants to market an implant with a different dose, they have to test at that dose before the FDA approves it.

Drug testing and approval is a very complicated business, involving scientists, physicians, lawyers, and reams of paperwork.

9 posted on 05/28/2016 5:23:44 AM PDT by exDemMom (Current visual of the hole the US continues to dig itself into: http://www.usdebtclock.org/)
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