Before a medication or new device for treatment of medical issues is available to the public, the United States Food and Drug Administration (FDA) must review and approve the medication or device for public use. The FDA does this to learn more about the product and make sure that it is effective and safe.
To get FDA approval, the company that makes the medication or device is required to conduct clinical research studies.
The companies ask people to volunteer for clinical research studies. In these studies, volunteers are given the investigational medication or device and are evaluated by study doctors and staff members.
After clinical research studies are completed, the pharmaceutical company submits the study information to the FDA. The FDA reviews this information and decides if the investigational medication or device can become available to the public..