How Are New Drugs Evaluated by the FDA?
As a physician who works at the FDA, I get a lot of questions from my medical colleagues. Well, sometimes they are questions -- and other times they are merely venting frustrations. "Why don't you regulate drug prices? Why are there so many drug ads on television? What the heck is a biosimilar?"
But as more of my friends learn what I actually do, they've been asking me just how does the FDA make decisions on whether or not to approve a drug. Specifically, they want to know how many people are needed in clinical trials to make decisions on whether a drug works, and if it is safe. I don't know about you, but I don't think this was ever covered in a pharmacology class.
I have always been interested in data and the FDA is a great place for those fellow lovers of data. But I have learned...
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