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FDA Removes 27 Companies From List Of Vendors Who Have Notified Agency They Are Selling Coronavirus Antibody Tests And Plan To Apply For Emergency Use Authorization

  • May 22, 2020

Reuters (5/21, Maddipatla) reports the FDA “has removed 27 makers of coronavirus antibody tests from its list of vendors who have notified the agency that they were selling a test and plan to apply for emergency use authorization.” Reuters adds, “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.”