Under the FDA's current rules, a vendor must notify the agency it is selling a test, label it as unapproved and submit a request for emergency use authorization within 10 business days from when the test was validated by a certified lab.The antibody tests removed include those from vendors who voluntarily withdrew and those for which there is not a pending request for the emergency use authorization, the agency said.
FDA says 27 coronavirus antibody tests no longer comply with its rules
By REUTERS
05/17/2024 12:10 AM
By REUTERS
05/16/2024 11:19 PM
By REUTERS
05/16/2024 11:15 PM
By REUTERS
05/16/2024 06:31 PM
By REUTERS
05/16/2024 05:36 PM
By REUTERS
05/16/2024 05:10 PM
By REUTERS
05/16/2024 03:31 PM
By REUTERS
05/16/2024 03:22 PM