World OF DRUG SAFETY MODULE

Introduction

The Office of Surveillance and Epidemiology (OSE) in FDA's Center for Drug Evaluation and Research monitors the safety of medicines once they are on the market. This is called post-marketing safety or post-approval safety.

There are three principal components of FDA's post-marketing activities:

• safety
• product quality
• advertising

OSE concentrates on safety.

OSE's mission is to evaluate drug risks and promote the safe use of drugs. The mission is not just to ensure that drugs are safe but to ensure that people use drugs safely. A lot of harm can occur when people use medicines improperly or incorrectly.