How are new drugs approved?
Before a medication can be prescribed, it must undergo an extensive testing and approval process. First, the investigational medication goes through rigorous preclinical testing. If it is permitted by regulatory agencies for the next phase of drug development, the investigational medication is then tested for safety in humans through clinical research studies. If endorsed by regulatory agencies after that, the investigational medication is further tested for both safety and effectiveness in patients with the disease or disorder it is intended to treat. The sponsor then submits a report (New Drug Application) to the appropriate regulatory authority, who either approves it, rejects it, or requires more testing.