FDA official says approval deadlines will be broken

The FDA is sending signals that it will start to let deadlines for drug approvals go by the wayside. In Vivo has picked up a report in BioCentury that John Jenkins, the head of the FDA's Office of New Drugs, is providing unofficial permission to miss deadlines. With the agency facing a series of stiff new challenges, the BioCentury report suggests that 10 percent of deadlines could be busted. That would be an enormous blow to drug developers, who have provided huge sums to the FDA in fees in return for its assurance that it will stick to a relatively secure timeline for approvals. Missed deadlines would translate into higher costs and lost revenue, something the industry isn't likely to take lying down.

"We are having to prioritize. We are having to set aside some things, hopefully on a temporary basis, until we can get adequately staffed," Jenkins reportedly told BioCentury. Get ready for the backlash, though.

- read the report on the report in the Wall Street Journal

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