US FDA sets up board to oversee drug exclusivity determinations
XLV•The FDA’s Center for Drug Evaluation and Research formed a board to oversee certain drug exclusivity decisions, aiming to improve their clarity and consistency. The board will focus on five-year new chemical entity exclusivity, three-year new clinical trial exclusivity and exclusivity for biological products.
1. Board oversight scope
The FDA’s Center for Drug Evaluation and Research formed a board to oversee and advise on certain exclusivity determinations, including whether exclusivity should be granted, its type and its scope. The board will focus on five-year new chemical entity exclusivity and three-year new clinical trial exclusivity, and will also advise on exclusivity for biological products.
2. Other responsibilities
The board will not review other types of exclusivity. It may also evaluate and recommend changes to CDER policies and practices relating to exclusivity and maintain records of determinations.
