FDA Must Craft Better EUA Policies For Tests, OIG Says

By Jessica Karins / September 23, 2022 at 4:14 PM
HHS’ Office of the Inspector General says FDA should rethink and revise its policies around granting emergency use authorization to tests during public health emergencies, and better prepare for future emergency test needs by expanding resources and information for developers about the EUA process, improving communication with laboratories to identify issues with testing, and helping develop a national testing strategy that goes beyond the EUA process. FDA agrees with OIG’s recommendations, which were included in a 51-page report assessing how...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.