FDA shifts policy to require antibody test makers to promptly seek emergency use authorization

FDA shifts policy to require antibody test makers to promptly seek emergency use authorization

The new policy, announced Monday, requires commercial manufacturers to submit emergency authorization requests, along with validation data for their antibody tests, within 10 business days. The FDA is also setting specific performance recommendations for all test developers. The agency also said it has the capability, working with the National Cancer Institute, to independently validate antibody […]