REGULATORY UPDATE: CBER Issues Updated 2022 Guidance Agenda

The Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) issued a May update to the 2022 Guidance Agenda. In the “Blood and Blood Components” category, CBER has added two guidance documents, “Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components” and “Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria.”

In the “Tissues and Advanced Therapies” category, the agency has added the draft guidance, “Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products.” Finally, FDA intends to issue the guidance, “Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridioides difficile Infection Not Responsive to Standard Therapies.”

AABB invites members with questions to contact regulatory@aabb.org.