Key facts
- The FDA's Center for Drug Evaluation and Research (CDER) established the board.
- The board will oversee 5-year new chemical entity exclusivity.
- It will also oversee 3-year new clinical trial exclusivity grants.
- The board may recommend policy changes related to exclusivity.
The US Food and Drug Administration's drug evaluation department announced on Friday, October 13, 2026, the formation of a new board tasked with overseeing and advising on drug exclusivity determinations. This initiative aims to improve the clarity and consistency of decisions regarding market protection for newly approved drugs.
The board will specifically focus on granting 5-year new chemical entity exclusivity, which is awarded to drugs with active ingredients not previously approved by the FDA. It will also oversee 3-year new clinical trial exclusivity grants for drugs using existing active ingredients but requiring new clinical studies funded by the sponsor.
Additionally, the board will provide advice on exclusivity for biological products. However, it will not review other types of exclusivity. The board may also evaluate and recommend changes to CDER's policies and practices concerning exclusivity determinations and maintain related records.