FDA Clarifies Status of COVID-19 Guidance Documents Ahead of PHE Expiration

by t_king

FDA Details Status of COVID-19 Guidance Documents

The U.S. Food and Drug Administration (FDA) has provided an update on the status of guidance documents related to the COVID-19 public health emergency (PHE) that was declared by the Secretary of Health and Human Services on January 31, 2020, through a Federal Register notice. The PHE was renewed and is expected to expire on May 11, 2023.

Due to many of the guidance documents being linked to the duration of the PHE, the Federal Register notice clarifies which guidances will no longer be in effect and which ones will be revised to remain in effect after the PHE declaration ends. However, it is important to note that the termination of the PHE declaration will not affect the Center for Drug Evaluation and Research’s (CDER) ability to authorize emergency use of COVID-19 treatments while the applicable declaration enabling the issuance of Emergency Use Authorizations (EUAs) under section 564 of the Federal Food, Drug, and Cosmetic Act is still in place.

This announcement highlights the FDA’s commitment to keeping regulatory guidance related to COVID-19 up-to-date and clear, even as the public health emergency declaration eventually expires. To read more about guidance documents related to COVID-19 click here.