Individual Case Safety Reporting - ICSR

The FDA requires the submission of drug post marketing safety reports in electronic format under the final rule (81 Federal Register 92603). Submission processing times are critical, depending on the type of safety report. ThinSpring provides real-time drug safety report authoring tools and submission services. You can upload existing Individual Case Safety Report files and edit or create new reports. Once the report is complete you request the electronic submission of the report using ThinSpring's full-time AS2 connection to the FDA Electronic Submission Gateway. Electronic submission receipts are tracked until your report is loaded in the FDA Adverse Event Reporting System - FAERS.

FDA Adverse Events Reporting System (FAERS)