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FDA: US leads with new drug approvals

The US regulator approved more new drugs in the last 12 months than its counterparts around the world

US regulators approved more new drugs over the last 12 months than any of their counterparts around the world, according to new figures from the FDA.

The US regulator passed 35 new medicines in the last year, its second highest total in the past decade after the 37 new drugs that gained FDA backing in 2009.

The regulator was also keen to point out that 24 of the 35 approvals occurred in the US before any other country in the world and also before the European Union.

FDA commissioner Margaret Hamburg: “Thirty-five major drug approvals in one year represents a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients.

“We are committed to working with industry to promote the science and innovation it takes to produce breakthrough treatments and to ensure that our nation is fully equipped to address the public health challenges of the 21st century.”

The FDA's FY 2011 Innovative Drug Approvals report details how the regulator used expedited approval authorities, flexibility in clinical trial requirements and resources collected under the Prescription Drug User Fee Act (PDUFA) to boost the number of innovative drug approvals for the fiscal year ending 30 September 2011.

The report also showed:

• Two-thirds of the new approvals were completed in a single review cycle, meaning sufficient evidence was provided by the manufacturer so the FDA could move the application through the review process without requesting major new information

• Almost half (16) of the drug were approved under 'priority review', in which the FDA has a six month goal to complete its review for safety and effectiveness

• Three were approved using 'accelerated approval', where the FDA approves safe and effective important new drugs quickly and then relies on subsequent post-marketing studies to confirm clinical benefit

• The approvals included 10 orphan drug in the last year

4th November 2011

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