REGULATORY UPDATE: FDA Revises 2022 CBER Guidance Agenda

The Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) issued a June update to the 2023 Guidance Agenda.

In the “Therapeutic Products” category, FDA added the guidance, “Potency Assurance for Cellular and Gene Therapy Products, Draft Guidance for Industry.”  In the “Other” category, the agency added the draft guidance, “Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center for Biologics Evaluation and Research Submissions.”

AABB notes a change in category name from “Tissues and Advanced Therapies” to “Therapeutic Products” in the June agenda. The remainder of the guidances CBER is considering for development during calendar year 2023 is unchanged.

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