Postmarketing Adverse Drug Experience Reporting

FDA regulations require the reporting to FDA of important adverse drug experience information associated with the use of unapproved-marketed prescription drug product. This information is used by FDA to determine at the earliest possible time whether to request a manufacturer, packer, or distributor to recall a product from the market or to recommend a seizure or injunction action to halt the marketing of the product and to remove it from the market. Such action, initiated promptly, may avert further adverse effects that may be associated with the use of the product.

The latest form for Postmarketing Adverse Drug Experience Reporting expires 2028-07-31 and is listed under ICR 202405-0910-001.

Reporting - AER Rx products not subject of marketing application

Federal Enterprise Architecture: Health - Public Health Monitoring