FDA approval process
They haven’t developed a drug for this yet? What does it mean to get a drug “approved”? Will my insurance cover it if it’s not FDA approved? I hear these questions all the time! They’re challenging to explain and a perfect opportunity for a blog post! When a company or a manufacturer thinks that they may have come up with a recipe for a medication, they have to test it on animals to make sure that it’s safe. Then, based on animal results, they need to let the FDA know, “hey, we think this would work well for people!”, and they submit an application called Investigational New Drug . This will allow them to enter the clinical stage of the testing, which has 3 phases in it. Phase one typically consists of making sure that the drug is as safe for humans as it was for animals. This will also help the manufacturer to know what kind of side effects they’re dealing with. So, now we know that the drug is safe for humans and animals, but does it work for what it’s supposed it?