FDA Authorizes Emergency Use of MERS Diagnostic Assay

Two days ago the Food and Drug Commissioner Margaret Hamburg authorized emergency use of the CDC's Novel Coronavirus 2012 Real-time RT-PCR Assay for the detection of the Middle East Coronavirus (MERS). Under the Pandemic and All-Hazards Preparedness Act which was enacted in 2006 reauthorized in March this year the FDA can allow limited use of a non-approved medical products to address public health emergencies. The FDA authorization grants public health laboratories in the US clearance to use the CDC's MERS detection kit to identify the virus in patient samples....Read Full Post
Source: About.com Biotech Biomedical - Category: Biotechnology Source Type: news