publication date: May. 9, 2014


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By Paul Goldberg

A study by a conservative think tank found large differences in performance of the FDA divisions, with oncology demonstrating the agency’s fastest time from application submission to approval.

Paradoxically, the Manhattan Institute found that the oncology division’s staff members had the agency’s highest workload—measured in INDs per staff member at the division.

In the study, the median time for approval at the slowest division is three times as long as the approval time at the fastest. The agency’s two fastest units, oncology and anti-viral, took under 200 days to make a decision on a drug. The neurology division took nearly 600 days to approve a drug.

Researchers gathered data measuring output and workload from the review divisions of the Center for Drug Evaluation and Research from 2004 to 2012. The divisions accounted for 184 new drugs or biologics and 80 percent of all new CDER-approved drugs over the period.

“We agree that there are differences in the average time it takes to approve drugs across CDER’s different review divisions,” said Stephanie Yao, an FDA press officer. “However, we believe that these differences are not an indicator of inconsistencies in efficiency but are rather a reflection of the different types of drugs and disease conditions we review, which also vary considerably across CDERs numerous review divisions.

“For example, some review divisions, such as oncology and anti-viral drugs, receive a high proportion of drugs designated for ‘priority review,’ which provides for a shorter regulatory review clock for drugs that represent significant improvements over … Continue reading 40-19 Cancer Unit Fastest in Approval Despite Having Highest Workload

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