How FDA’s Adverse Event Reporting System Impacts Drug Cos.

Law360, New York (August 8, 2013, 1:15 PM EDT) -- For those companies that missed it, the 2007 Food and Drug Administration Amendments Act (FDAAA) requires that the U.S. Food and Drug Administration publish quarterly reports that list “potential signals of serious risks/new safety information” of FDA approved medications. Although the FDA’s processes and procedures for evaluating risks sufficient enough to warrant publication in these reports are unclear, drug companies with FDA-approved drugs on the market should know about these requirements.

For example, recently, the FDA announced that Tylenol and other acetaminophen-containing pain killers can cause...
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