World of Compliance Module

Adverse Drug Experience (ADE) Reporting Program

The Adverse Drug Experience (ADE) reporting program ensures that safety reviewers receive required drug product safety data. The ADE does inspections, education and outreach. ADE investigators inspect safety at company offices and examine how safety issues are tracked.

On-site inspections by local staff determine if firms are collecting, processing and submitting accurate and complete ADE data to FDA in a timely manner. In addition, ADE inspectors determine if firms have adequate written procedures for the surveillance, receipt, evaluation and submission of postmarketing ADE reports.