On Nov. 22, 2023, the U.S. Food and Drug Administration issued the final guidance COVID-19: Developing Drugs and Biological Products for Treatment or Prevention. The guidance provides updated recommendations that reflect the evolving scientific knowledge and the current state of the pandemic. This supersedes the final guidance of the same name initially issued on May 12, 2020 and reissued on Feb. 22, 2021.

The guidance provides FDAﾒs current recommendations on the design of phase 2 and phase 3 trials with a focus on trial population and design, efficacy endpoints, as well as safety and statistical considerations.