The FDA's role in the drug approval process

This article provides information about the fda facility inspections for approving medications — the US Food and Drug Administration.

The U.S. Food and Drug Administration (FDA) examine, evaluate and approve a wide range of products for medical use, including drugs, medical devices, foods, cosmetics and many other health-related products. In other words, FDA approval means that the FDA has decided that the benefits of the approved product outweigh its potential risks.

Before the FDA, companies that make claims about a product that it was safe or even that it worked. This made consumers extremely vulnerable. Currently, new products must undergo the FDA approval process before they are available to the public.

Why is the FDA approval process important?

FDA approval is important because it validates the need for research studies on how drugs work in children, not just adults. It also allows us to determine the appropriate dose for children, determine the best way to administer them and evaluate any interaction between medications.

How does a medication or device achieve FDA approval?

In order for a medication or medical device to receive FDA approval, the manufacturer must demonstrate to the FDA that the product is safe and effective. Although there is no risk-free medication or medical device, research studies and tests must show that the benefits of the medication or device for a certain condition outweigh the risks that the patient may take when using the product. Read more