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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