Approved Drug

Definition

A medication approved for marketing. In the US, the Food and Drug Administration (FDA) must approve a substance as a drug before it can be marketed. The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA approval/rejection of application.

 

 

Other Medical Definitions

• Over-The-Counter (OTC) Drug
• Selective Estrogen-Receptor Modulator (SERM)
• Adult-Onset Diabetes
• Metabolic Syndrome
• Donor, Universal
• Colon Syndrome, Nervous
• Disease, Anderson-Fabry
• Heart Murmur
• Anal Fistula
• Heart Rate