www.fdanews.com/articles/150797-pharma-blog-watch
Pharma Blog Watch
November 6, 2012
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.
“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.