REGULATORY UPDATE: FDA Announces Plans for Guidance Documents Issued During COVID-19 PHE

The Food and Drug Administration published a Federal Register notice (FRN) on Monday that addresses the future of 72 COVID-19-related guidance documents still in effect as the agency prepares for the end of the COVID-19 public health emergency (PHE) on May 11.  

Twenty-two guidance documents will expire with the PHE, while an additional 22 guidance documents will expire after a 180-day wind-down period that ends on Nov. 7.  

FDA identified 24 COVID-19-related guidances that the agency intends to retain with appropriate revisions after the expiration of the COVID-19 PHE declaration. These guidances will remain in effect for 180 days after the end of the PHE, during which time FDA will release revised guidances with changes based on comments received and the agency’s experience with implementation. This includes the following guidance documents related to blood and biotherapies: 

• Investigational COVID-19 Convalescent Plasma. 
• Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products. 
• Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency.  

The FRN also identified four guidance documents related to COVID-19 whose duration was not tied to the COVID-19 PHE declaration. These guidance documents will remain in effect after the expiration of the COVID-19 PHE declaration.  

Members with questions may contact AABB’s Regulatory Affairs team.