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Latest From Sanochemia Pharmazeutika AG
Expect More Temporary Members Voting In US FDA Advisory Committees
Reform efforts in CDER include ensuring expertise is specific to the issues being discussed, which may mean more temporary voting members on advisory committees.
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.
Supplemental Filings: Back To US FDA’s Conference Center, What Marks Wants In A Gene Therapy Director, And More
Short stories about how US FDA’s conference center changed since COVID-19 forced the end of in-person public events, what the agency did to officially close the books on Makena, and more.
News We’re Watching: Cancer Screening Partnership, New Abbott Electrophysiology Head, V-Champs AI Challenge
This week, Bioventus announced plans to sell its wound business; Pfizer and Thermo Fisher Scientific partnered to increase cancer screening access; and the FDA expanded the magnetic resonance imaging labeling for Abbott’s Eterna spinal cord stimulator.
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