Wayne Matelski

Wayne Matelski

ArentFox Schiff

Contact
View Bio
RSS

Latest Posts › Diagnostic Tests

Share:

Long COVID – Just the Facts

The Food and Drug practice at ArentFox Schiff has received numerous inquiries from clients about long COVID, so we decided to ask our in-house scientist, Robert Edwards, Ph.D., Director of Regulatory Science, to prepare an...more

6/15/2022  /  Affordable Care Act , Canada , Centers for Disease Control and Prevention (CDC) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Diagnostic Tests , Food and Drug Administration (FDA) , Risk Factors

FDA Authorizes First Genomic Sequencing COVID-19 Test

On June 10, 2020, the FDA issued an emergency use authorization (EUA) for the first molecular diagnostic test that can generate information about the genomic sequence of the COVID-19 virus. The EUA was issued to Illumina,...more

6/15/2020  /  Coronavirus/COVID-19 , Diagnostic Tests , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Virus Testing

FDA Updates List of US Facilities That Perform COVID-19 Testing As of March 23

FDA has just issued what it calls “FAQs on Diagnostic Testing for SARS-CoV-2” that provides information on which tests and which testing laboratories have received Emergency Use Authorization for the testing for the COVID-19...more

3/26/2020  /  Clinical Laboratories , Coronavirus/COVID-19 , Diagnostic Tests , Emergency Use Authorization (EUA) , FDA Approval , Food and Drug Administration (FDA) , Laboratory Developed Tests
3 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide