World OF DRUG SAFETY MODULE

Pharmacovigilance Tools for Risk Assessment and Evaluation

OSE evaluates the safety of marketed medicines. OSE reviews adverse event reports in collaboration with the CDER Office of New Drugs. FDA takes a lifecycle approach to drug safety. The Agency looks at a medicine continuously from the earliest test tube experiments all the way through large phase 3 studies, and then throughout the post-marketing period.

Click the thumbnail on the right to view a graphic that illustrates key steps and timelines in the U.S. drug development and review process.

For more information about the drug development and review process, please visit: The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective