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The Next Step In FDA Reform? Consolidated Drug/Device Groups Proposed By FOCR

This article was originally published in RPM Report

Executive Summary

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.


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