NIH, FDA act to increase access to over-the-counter COVID-19 tests

The National Institutes of Health will use $70 million from the American Rescue Plan Act for a program to speed development of accurate and reliable over-the-counter tests for COVID-19, the Department of Health and Human Services announced today. The NIH Independent Test Assessment Program will work with the Food and Drug Administration, manufacturers and experts to speed emergency use authorizations for new tests that can increase production quickly, officials said.

In related news, FDA recommended labeling updates to facilitate over-the-counter single-use testing for symptomatic individuals for tests currently authorized only for serial testing. It also granted an emergency use authorization to Celltrion Diatrust for an over-the-counter rapid antigen test, and reauthorized the Quidel QuickVue at-home test to add over-the-counter single-use testing for symptomatic adults and children.