Medical Devices Law & Industry Report | Diagnostic Tests: Did FDA Create a Way Forward for Lab-Developed Tests?

In the past week, the FDA Vaccines and Related Biological Products Advisory Committee recommended authorization of the Pfizer-BioNTech vaccine for use in children 5–11 years of age. The CDC formally endorsed the booster dose for the Moderna and J&J vaccines. President Biden met with Dr. Robert Califf for the top FDA post. See details for these and other supply chain developments in the Medical Products Supply Chain Week in Review. 

Our Health Care Group explains how emergency use authorizations (EUAs) have been issued during the current public health emergency and the benefits and limitations of offering a test pursuant to an EUA and provides practical advice for test developers preparing for the end of the public emergency. 

President Biden signed the Executive Order on America’s Supply Chains, kicking off a comprehensive review of supply chain risks. Meanwhile, the FDA issued an EUA for the Janssen COVID-19 vaccine. Read the details in the COVID-19 Medical Products Supply Chain Week in Review.