Electronic submission of postmarketing drug and therapeutic biological product safety reports has become possible through the development of several FDA initiatives. Within the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), the development and deployment of the Adverse Event Reporting System (AERS) has made it possible to receive and process postmarketing safety reports electronically. In addition to AERS, a revitalized pharmacovigilance program, new regulations, and international harmonization agreements have contributed to FDA's ability to implement its electronic submissions of postmarketing safety reports program.

Electronic submissions provide FDA and the public with several tangible benefits. Specifically, automating the receipt and processing of postmarketing safety reports will allow FDA to:

• Be more responsive to public health issues
• Reduce resources associated with data management
• Apply better data and better science to the drug regulatory process

This site is intended to provide drug and therapeutic biological product  manufacturers, distributors, packers, and other interested parties with information about AERS and how to submit postmarketing safety reports to FDA in an electronic format.

To learn more about submitting reports electronically go to Introduction to AERS Electronic Submissions.  Go to Postmarketing Safety Reporting for additional information about these reports.

Send Comments and Questions to:  (AERSESUB@cder.fda.gov)