CBER/CDER Consolidation Working Group Set To Meet Week Of Sept. 16
FDA's working group on CBER/CDER consolidation will meet for the first time the week of Sept. 16
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A Friends of Cancer Research proposal to create FDA drug-device review teams in oncology, cardiology and neurodegenerative disease could find a home in the next round of FDA reform legislation. PDUFA VI. Current and former agency officials are cautiously optimistic about the idea, but combining review operations with different statutory underpinnings will be challenging.
FDA is understood to be finalizing a plan for a new office of cancer therapeutics that would merge the current drug and biologics review groups within the Center for Drug Evaluation & Research's Office of New Drugs