Tag Archives: COVID-19

FDA Grants COVID-19 Diagnostic Emergency Use Authorizations, And Other Recent FDA Actions to Address COVID-19

The U.S. Food and Drug Administration (FDA) issued two Emergency Use Authorizations (EUA) for commercially distributed COVID-19 diagnostic tests at the end of last week.  The first authorization was issued to Roche Molecular Systems, Inc., for its cobas SARS-CoV-2 Test, and the second issued the following day to Thermo Fisher Scientific, Inc., for its TaqPath … Continue Reading

FDA Postpones Ex-US Facility Inspections

U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, M.D., announced that FDA is postponing foreign inspections through April 2020 in response to the COVID-19 outbreak.  Manufacturers, including contract manufacturers, anticipating post-approval inspections may welcome the news, given other pressing issues facing ex-US facilities (i.e., facilities located outside the US) in light of COVID-19.  … Continue Reading
LexBlog

By scrolling this page, clicking a link or continuing to browse our website, you consent to our use of cookies as described in our Cookie and Advertising Policy. If you do not wish to accept cookies from our website, or would like to stop cookies being stored on your device in the future, you can find out more and adjust your preferences here.

Agree