FDA Issues Emergency Use Authorization for Roche Zika Test | Pharma Industry Regulation | Scoop.it

The U.S. Food and Drug Administration on Monday issued emergency authorization for a Zika diagnostics test from Swiss drugmaker Roche, skirting normal approval channels as the regulator moves to fight the disease's spread.

Zika virus, detected in Brazil and elsewhere last year before spreading to the Americas, is associated with microcephaly, a birth defect characterized by an unusually small head and potential developmental problems.

Through last week, the United States reported 2,517 Zika cases, 29 of which were likely acquired locally in Florida through mosquito bites and the rest brought in by travellers, the U.S. Centers for Disease Control and Prevention (CDC) said.

 

The FDA issues such Emergency Use Authorization during public health emergencies, to quickly deploy unapproved medical products for as long as they are needed.