The FDAs Drug Review Process Ensuring Drugs Are Safe and Effective

The FDA s Drug Review Process Ensuring Drugs Are Safe and Effective 

Prescription drug users assume that products approved by the FDA are safe but know little about what goes into the review process. This document, updated July 10, 2009, describes the process and defines some commonly used terms. 

The path a drug travels from a lab to your medicine cabinet is usually long, and every drug takes a unique route. Often, a drug is developed to treat a specific disease. An important use of a drug may also be discovered by accident 

Investigational New Drug Application (IND)—The pharmaceutical industry sometimes provides advice to the FDA prior to submission of an IND. Sponsors—companies, research institutions, and other organizations that 

Clinical Trials—Drug studies in humans can begin only after an IND is reviewed by the FDA and a local institutional review board (IRB). The board is a panel of scientists and non-scientists in hospitals and research institutions that oversees clinical research. 

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Meadows, Michelle. The FDAs Drug Review Process Ensuring Drugs Are Safe and Effective. FDA Consumer 36, no. 4 (July/August 2002) ... 

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