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FDA’s Very Big Year: Drug Approvals Approach Record Levels

This article was originally published in RPM Report

Executive Summary

In 2012, FDA new drug approvals reached levels not seen since the peak years of the 1990s. FDA counts 39 NMEs; The RPM Report tracks a different metric—ICTs—and FDA topped 30 for the first time since 1999. The approval spike clearly reflects a regulatory agency operating at peak efficiency. Is there also (at last) a true bulge in innovative products making it through development?


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