Pazdur Unplugged: US FDA’s “Project Livin’ Label” Shows Back Story On Cancer Drug Approvals
Executive Summary
Latest Oncology Center of Excellence initiative is officially a CME effort designed to encourage practitioners to make full use of the information in the approved drug labeling. It is also a surprisingly effective way to explain drug approvals in a flattering light for regulators and sponsors.
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The Power Of The Open Public Hearing
The US FDA took three high profile applications to an external advisory committee meeting during the week of 8 May – and offered a very skeptical read on the approvability of each. All three won positive votes from the committees, in no small part thanks to the messages delivered during the Open Public Hearings.