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May 22, 2020

Health Law Daily

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.”