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

16 Jan 2013

• By Michael McCaughan

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?

No matter how you count, 2012 was a very good year for new drug approvals.

The Center for Drug Evaluation & Research highlights the number 39: that is how many new molecular entities and “novel”...