Adverse Drug Experience (ADE) Reporting Program
The Adverse Drug Experience (ADE) reporting program ensures that safety reviewers receive required drug product safety data from sponsors of approved drug products. Since the drug approval process often exposes only a few hundred or thousand patients to a drug in clinical trials prior to approval, the adverse experience reports for a drug are an important source of safety information when the number of patients or consumers exposed to the product greatly increase into the tens and hundreds of thousands to millions after product approval and marketing. The ADE program reviews the periodic mandatory reports that are received from sponsors. All manufacturers, packers, distributors and anyone whose name appears on the label, must also submit reports of adverse events.
