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U.S. Department of Health and Human Services

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Innovative Drug Approvals: 2011 Report

FY 2011 Innovative Drug Approvals Cover

FDA is approving innovative drugs earlier and faster than any other country in the world, while at the same time making sure that Americans’ medicines are safe and effective.

Over the last several years, FDA has improved the quality and speed of its drug approval process, making new treatments available for millions of Americans suffering from various serious health problems.

In Fiscal Year 2011 FDA approved 35 innovative drugs that offered important advances in treatment for hepatitis C, late-stage prostate cancer, lupus, drug resistant skin infections, pneumonia, and other serious and life- threatening diseases. This is among the highest number of approvals in the past decade, surpassed only by 2009 (37).

The report, FY 2011 Innovative Drug Approvals, provides details of how FDA used expedited approval authorities, flexible clinical trial requirements and resources collected under the Prescription Drug User Fee Act (PDUFA) to boost the number of innovative drug approvals.