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FDA In Twilight: Gov’t Shutdown Has Not Slowed Rx Operations Too Visibly Yet

 
• By Brenda Sandburg

Shutdown puts API shipments on a slow boat, but reviews of existing products can proceed with carry-over funds, even as new applications cannot be filed. CDC has largely halted its influenza program and NIH has ceased enrolling new patients in its clinical center.

The pharmaceutical industry has not faced major disruptions at FDA from the government shutdown. That of course will change if the closure continues and carry-over user fees run out.

With 45% of its staff furloughed by the shutdown, FDA has had to curtail numerous activities, including review of pending biosimilars submissions and acceptance of new drug applications

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