Sentences with phrase «emergency use authorization»

When the swine flu broke out earlier this year, the FDA issued the Emergency Use Authorization which approved two tests developed by other companies for immediate use to detect the H1N1 strain.

A total of 100 semen samples were spiked with a recombinant Accuplex ZIKV (SeraCare Life Sciences) at 5 viral copies per ml and processed in Aptima Urine Transport medium (Hologic Inc.) and tested using Aptima ® ZIKV assay released under the FDA's emergency use authorization on the fully automated Panther system from Hologic, Inc..

The gadget is still under scrutiny of the Food and Drug Administration, something that executives from Theranos hoped to fast - track under the emergency use authorization for Zika detectors.

The Food and Drug Administration (FDA) has given Emergency Use Authorization (EUA) to digital health firm Nanobiosym's on - site Zika virus testing platform.

AmpliPhi and Adaptive Phage Therapeutics have successfully treated more than two dozen patients with life - threatening conditions and are currently treating a few others under an emergency use authorization granted by the US Food and Drug Administration.

Not exact matches

Several commenters further recommended that only the following uses and disclosures be permitted for research information unrelated to treatment without authorization: (1) For the oversight of the researcher or the research study; (2) for safety and efficacy reporting required by FDA; (3) for public health; (4) for emergency circumstances; or (5) for another research study.

A few comments said that, except in limited circumstances or emergencies, covered entities should be required to obtain authorization before using or disclosing protected health information.