Inspection Questions Delay CBER’s Embrace Of Real-Time Oncology Review

The oncology branch of the US FDA’s biologics center does not believe RTOR would speed application reviews.

A scientist in sterile coverall gown pipetting medium or reagents for cell culture experiment in biological safety cabinet.
The complex biologic manufacturing process could limit the applicability of real-time review. • Source: Shutterstock

Real-time review has not reached oncology work in the US Food and Drug Administration’s Center for Biologics Evaluation and Research, despite being on the cusp of expanding beyond the pathway’s pioneering product sector.

Peter Bross, acting chief of the oncology branch in the CBER Office of Tissues and Advanced Therapies Division of Clinical Evaluation and Pharmacology/Toxicology, said that “we have not yet adopted” the program, which allows earlier submission of

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