An approved drug is a preparation that has been validated for a therapeutic use by a ruling authority of a government.
In the United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo the FDA's approval process. This process involves first testing the drug on animals or in medical labs. If found to be safe by the FDA and approved for the next phase of study, the drug is then tested for safety and effectiveness in humans (clinical trials). The drug manufacturer then files a New Drug Application to the FDA, which reviews the application and either approves or rejects it.
On average, only one in every 5,000 compounds that makes it through lead development to the stage of pre-clinical development becomes an approved drug. Only 10% of all drugs started in human clinical trials become an approved drug.
- Drug discovery
- Drug design
- Drug development
- Abbreviated New Drug Application
- Patent medicine
- Dietary supplement
- Folk remedy
- ClinicalTrials.gov from US National Library of Medicine
- ICH Website
- FDA Website
- Simple Steps for Using Medications Safely by FDA