FDA Update

Standards Change as COVID Pandemic Ends

FDA Explains What Will Happen to CDER Guidances and Emergency Use Authorizations as the Public Health Emergency Ends

The U.S. Food and Drug Administration published a Federal Register notice explaining the status of guidance documents addressing the COVID-19 public health emergency (PHE), which the Secretary of Health and Human Services declared on Jan. 31, 2020, and subsequently renewed, under section 319 of the Public Health Service Act (319 PHE declaration).

FDA expects the 319 PHE declaration to expire on May 11, 2023. Because many of the guidance documents issued during the PHE to address COVID-19 were tied to the duration of the PHE, the Federal Register notice clarifies when certain guidances will no longer be in effect and which guidances FDA is revising to continue in effect after PHE declaration ends.

Please see the Federal Register notice for details on the status of specific guidances, including Center for Drug Evaluation and Research (CDER) guidances related to the PHE.

Importantly, the termination of the 319 PHE declaration will not impact CDER’s ability to authorize COVID-19 treatments for emergency use while the applicable declaration enabling the issuance of EUAs under section 564 of the Federal Food, Drug, and Cosmetic Act is in place. For more information on this topic, please refer to FDA’s website.

In the coming weeks, CDER will work to update its existing webpages containing COVID-19 information to ensure they show the most up-to-date information.

Questions

For more information on CDER Guidances and EUA please email us at: info@mdiconsultants.com and ref: CDER Guidances and EUA.