ADVERSE REACTION: (Adverse Event): Also known as side effects, adverse

reactions include any undesired actions or effects of the experimental drug or treatment.
Experimental treatments must be evaluated for both immediate and long-term side
effects.
APPROVAL: A drug, device or biologic must be approved by a country’s regulatory
agency before it can be marketed. The approval process involves several steps
including pre-clinical (animal) studies, clinical trials for safety and efficacy, filing of a New
Drug Application (NDA) in the United States or Marketing Authorization Application
(MAA) in Europe by the manufacturer, regulatory agency review of the application, and
agency approval/rejection of application.