Late last week, the U.S. Food and Drug Administration (FDA) announced it approved the use of spun synthetic swabs similar to Q-tips for use in testing for COVID-19....more
4/22/2020
/ Biologics ,
Clinical Evaluations ,
Clinical Laboratories ,
Clinical Laboratory Testing ,
Clinical Trials ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Good Clinical Practices ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Product Labels ,
Virus Testing
The Food and Drug Administration has taken many steps to assist in the response to the COVID-19 health crisis, including easing regulations, expediting the availability of necessary medical equipment, and creating streamlined...more
In mid-March, the US Food and Drug Administration announced via press release an “unprecedented policy” to increase testing capacity for COVID-19 in the United States. As part of its Policy for Diagnostic Tests for...more
4/17/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Clinical Laboratories ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Guidance Update ,
Laboratory Developed Tests ,
Legislative Agendas ,
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Public Health Service Act ,
Regulatory Oversight