May 17, 2020

Number Of FDA Approvals Reached 15 Year High In 2012

FDA
drug approvals
oncology drugs
PDUFA
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2012 Saw A 15 Year Record High For FDA Drug Approvals
Follow @HealthCareG Recent reports state that drug approvals by the U.S. Food and Drug Administration reached a 15 year high in 2012. The FDA approved...

 

Recent reports state that drug approvals by the U.S. Food and Drug Administration reached a 15 year high in 2012. The FDA approved a total of 39 novel medicines last year, an increase of 30 percent when compared to a year ago.

Oncology drugs lead the way with 11 new drugs approved last year. Over the last ten years the number of FDA approvals had averaged roughly 23 a year. The passage of the Prescription Drug User Fee Act (PDUFA) played a major role in the sharp increase in approvals.

The PDUFA “has provided critical resources for improving the quality and timeliness of premarket review of drugs,” said FDA spokeswoman, Sandy Walsh. “These accomplishments could not have been achieved without the innovations of the biopharmaceutical industry and the dedication and skill of FDA's drug review staff.”

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