At present, FDA tracks those adverse events through a hybrid voluntary/mandatory reporting model which feeds data into its FDA Adverse Event Reporting System (FAERS).
But over the last few years, FDA has expressed interest in moving past individual reports about patient experiences and moving toward "big data" approaches. Last year, FDA proposed a new surveillance program within its Office of Clinical Pharmacology (OCP) known as the Pharmacological Mechanism-Based Drug Safety Prediction (PMDSP) program.
The program, according to FDA, was to mine data and recognize patterns through the use of technology in order to find as-yet unrecognized safety signals.
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