“ FDA Approved” is probably the most sought-after descriptor to any medication and device because it only means one thing – they are effective and safe to be sold and prescribed to the public.
The Food and Drug Administration (FDA) is the agency responsible for regulating medical drugs, including prescription medications, over-the-counter medications and vaccines, as well as medical devices, such as mechanical heart valves, infusion pumps and stents. They make sure that any of these medication or device have more benefits and won’t pose significant risks like death to the public. That’s why it usually takes years, 10 to 15 years even, to obtain FDA approval.
So what does it take to get their approval?
Imagine the process of going through the school system. It’ll take you roughly 15 years to pass elementary school, high school, and then, college. You’ll need to undergo the grueling process of submitting requirements, taking tests and passing your thesis defense. And when you’re done, you’ll get your diploma as proof.
This is similar to how FDA approval works. Each medication has phases, and each phase tests a different aspect.
- Pre-clinical phase: It’s first phase, where most of the work is in laboratories. This is where they determine the basic concerns about safety – is it safe to take? What is the intended effect? Are there side effects?
- Clinical phase or clinical trials: The second phase of the study, where a large group of volunteer patients take part in the tests. The goal is to prove that the medication is working according to its intended use.
Based on all the data from the different testing phases, the FDA will decide if it will be approved or not. If approved, doctors can prescribe the medication or medical device to their patients. Sounds pretty simple, right? But the process doesn’t just end there.
To protect the public, the FDA continues to monitor the medication or medical device even after it has been made available to the public. So the next time you purchase medicine or a medical device, make sure it’s FDA approved.
