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.
- Printer Friendly PDF (4.84MB)
- Persons with disabilities having problems accessing the above pdf file may call 301-796-4800 for assistance.
- Press Release - FDA: Successful year for new drug approvals
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