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Drug Safety in Post-FDAAA Era: An Epidemiologist's View

This article was originally published in RPM Report

Executive Summary

Bruce Psaty, longtime advocate of increased post-market safety controls for drugs, sees big challenges looming for FDA as it tries to adapt to the new authorities granted by the 2007 Food & Drug Administration Amendments Act. Psaty views the establishment of a large 100-million-life post-market surveillance system as a particularly daunting challenge.

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