fda.gov· FDA·· 6 hours agoPickScore53
CDER Exclusivity Board
CDER Exclusivity Board
In brief
FDA's Center for Drug Evaluation and Research has set up an Exclusivity Board to oversee and advise on certain exclusivity determinations, aiming for clarity and consistency. The Board covers 5-year new chemical entity exclusivity, 3-year new clinical trial exclusivity, and biological product exclusivity, but generally will not review 180-day generic drug, 7-year orphan drug, or 6-month pediatric exclusivity. It may also evaluate CDER exclusivity policies and keep records of determinations, and questions can be sent to its FDA email address.
Why it matters
FDA creates a new internal body shaping how drug and biologic exclusivity decisions are made.
Source: fda.gov · fda.gov