RMAT Designation, Gene Therapies Highlight 2017 CBER Transformation
CBER Director Peter Marks says the center implemented a lot in a short amount of time for the RMAT pathway.
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The latest drug development news and highlights from our US FDA Performance Tracker.
Former FDA heads reflected on instances when they experienced pressure from their higher-ups; speakers also offered praise for the job Commissioner Scott Gottlieb is doing at the agency.
CDER's OHOP, as well as relevant CBER and CDRH staff, should be folded into OCE, which should have final sign-off on all oncology products, ASCO and Friends of Cancer Research say.