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The Ex(clusivity) Factor (Drug Wonks Blog)
“Rather than speculating as to where the FDA may go in a post-PDUFA V world, it’s important to focus on where it has already gone,” blogger Peter Pitts writes. For one, the FDA has established a new review board within CDER — the CDER Exclusivity Board — tasked to help the agency make consistent findings on whether products should be granted periods of marketing exclusivity. “The board generally meets once or twice a month. Members review written submissions from sponsors and board members participate in meetings with sponsors regarding exclusivity determinations for their products,” Pitts writes.