FDA reviews continue for now

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Banked user fees are keeping the FDA review process humming for now, reports MedPage Today, which notes that the agency approved the prescription hot flashes medication Duavee Thursday and plans to hold its advisory committee meeting for Medtronic devices this week. This in addition to green-lighting an IV nutritional treatment called Clinolipid on Thursday.

The omega-three/omega-six fatty acid blend was granted priority review to alleviate a drug shortage. MedPage Today notes that although user fees fund the regulator's review processes, they only cover around two-thirds of the cost, putting future reviews in limbo under the shutdown. As noted last week, more than half of the non-furloughed FDA employees are funded by user fees, but only 55% of the agency's staff is allowed to work until the shutdown is resolved.
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