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REGULATORY UPDATE: FDA Updates 2022 CBER Guidance Agenda

June 24, 2022

The Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) issued a June update to the 2022 Guidance Agenda. 

In the “Tissues and Advanced Therapies” category, FDA added the guidance for industry, “Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial” finalizing a draft guidance of the same name issued in Sept 2021. The agency also revised the “Human Gene Therapy for Neurodegenerative Diseases; Draft Guidance for Industry” from a guidance to a draft guidance.

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