CDER has established 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. 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.
The Board will focus on 5-year new chemical entity (NCE) exclusivity, 3-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.
The Board generally will not review 180-day generic drug exclusivity, 7-year orphan drug exclusivity, or 6-month pediatric exclusivity, but it will communicate with other groups within FDA responsible for addressing these exclusivity issues, as appropriate. The Board also may evaluate and make recommendations regarding CDER’s policies and practices relating to exclusivity and maintain records of exclusivity determinations.
Questions regarding exclusivity matters may be submitted to CDERExclusivityBoard@fda.hhs.gov.