FDA Releases Draft Guidance on 'Deemed to be a License' Provision of Biologics Price Competition and Innovation Act of 2009

Summary

The US Food and Drug Administration (FDA) has published a draft guidance outlining its approach to implementing a provision of the Biologics Price Competition and Innovation Act of 2009, which grants automatic approval to certain biological products approved before March 23, 2020, under the Federal Food, Drug, and Cosmetic Act.