Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

Zika Assay Reviews Are Testing The Limits Of FDA Capacity, Shuren Says

Executive Summary

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.

Advertisement

Related Content

Short-Term US Funding Bill Passes With $1.1bn In Emergency Zika Funds
OUS Approvals Analysis: Expanded CoreValve Indication And Zika IVDs Among August’s CE Marks
Quest For Political Capital, Legacy Could Push 'Cures' Over The Finish Line
Hologic/Grifols, Roche Molecular Zika Tests Tapped For Blood-Screening Ramp-Up
House-Senate Conferees Fight Over Zika Funds As FDA Approves More Assays

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register