RAPS

FDA official: Clinical, CMC teams should be on the same page when developing CGTs

WASHINGTON – Denise Gavin, the director of the Office of Gene Therapy at the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), emphasized that clinical ...
RAPS

Postapproval CMC Changes: FDA Updates Guidance

Drug and biologics manufacturers looking to implement a chemistry, manufacturing and controls (CMC) postapproval change through the use of a comparability protocol (CP) should take note of an updated ...
FierceBiotech

The 2026 Cell Therapy Regulatory Landscape: Aligning CMC Strategy with FDA and EMA Expectations

In 2026, the global regulatory framework for cell-based therapies continues to evolve, placing increased emphasis on robust CMC control strategies, comparability planning, and lifecycle management. As ...
PharmTech

FDA Issues Guidance on Comparability Protocols

The guidance discusses the implementation of CMC postapproval changes through a comparability protocol. On April 19, 2016, FDA issued guidance on how to implement a chemistry, manufacturing, and ...