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FDA’s Adverse Event Reporting System (AERS) Database

BayBiotech.NET
AERS is a computerized information database designed to support FDA’s post marketing safety surveillance program for drug and biological products.
The AERS database is used to store and analyze data received in post marketing safety reports submitted in form of reports by companies. FDA recently proposed to submit the reports in electronic format in order to achieve the following objectives:
1. Eliminate the time and costs associated with submitting paper reports.
2. Expedite the agency’s access to safety information
3. Enhance agency’s ability to rapidly communicate information about suspected problems to health care providers, consumers, applicants, and sponsors within the United States and internationally.

The proposal is developed considering international standards guidelines (ICH) and was open for public comment between August- November, 2009. To read more about the proposed rules follow the link: http://edocket.access.gpo.gov/2009/pdf/E9-19682.pdf

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