Zika Assay Reviews Are Testing The Limits Of FDA Capacity, Shuren Says
As Congress squabbles over a federal funding bill to fight the virus, FDA reviewers are taking on extra duties and working overtime to approve Zika diagnostics quickly, device chief Jeff Shuren says. The most recent emergency-use authorization targeting Zika extended the usability of a Hologic assay to more patients.
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Congress managed to settle its disputes over funding riders Sept. 28 and passed a relatively clean bill that contains $1.1bn in emergency Zika virus response funding, and will keep government agencies – including US FDA – running at current spending levels until Dec. 9.
August was another slow month for announcements of medical device approvals outside the US, but the short list of non-US approvals this month includes a broad range of device-types approved, notably a much-awaited expanded indication for Medtronic’s CoreValve Evolut R, in six different territories.
When Congress returns to work after the summer recess, the House and Senate medical innovation packages may gain momentum as legislators seek a “feather in the cap” for reelection campaigns, and House Energy and Commerce Committee Chair Fred Upton and Vice President Joe Biden look to cement legacies, say legislative analysts. Also, a Zika virus funding rider is expected be attached to a continuing resolution.