FDA Clinical Hold And Refusal-To-File Actions To Be Reviewed By Internal Cmte.
A longstanding FDA committee has been restructured in the new year to refine the process of issuing clinical hold and refusal-to-file determinations
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Unlike trials of other ESAs, Roche’s Mircera studies excluded patients with elevated levels of C-reactive protein, a marker for inflammation. In a move reflective of growing use of interdisciplinary and cross-division expertise within FDA, the review division sought center-level “regulatory briefing” to determine if CRP screening produced a database that was not characteristic of the market. The briefing found the rate of exclusion due to CRP screening insufficient to delay approval of Mircera
The International Fragrance Association North America took a break from its higher-stakes advocacy work Nov. 1 to give lawmakers and congressional staffers a "scent experience." Perfumers from six of the group's biggest members were on hand with "Scents of Home," joined by Monell Center researchers to educate attendees on the mechanics of scent and the important role it plays in people's lives.