"New" CDER Exclusivity Board focuses on clarity and consistency of exclusivity decisions

The US Food and Drug Administration recently announced that the agency has established within the Center for Drug Evaluation and Research (CDER) an Exclusivity Board “to provide oversight and recommendations regarding exclusivity determinations made by the Center, with a primary focus on clarity and consistency of decisions,” notes Kurt Karst, writing on Hyman, Phelps & McNamara’s FDA Law Blog.

“The CDER Exclusivity Board will oversee certain exclusivity determinations, including whether and what type of exclusivity should be granted and the appropriate scope of exclusivity grants,” according to the announcement.

Furthermore, says the announcement, the Board will focus on five-year new chemical entity (NCE) exclusivity, three-year new clinical trial exclusivity, and exclusivity for biological products. The Board will not review or make recommendations with respect to all exclusivity determinations in these areas, but will assist the Center in resolving certain matters, including issues that arise in the context of specific requests for exclusivity.