FDA Sets Up Board to Oversee Drug Exclusivity Determinations
The U.S. Food and Drug Administration's drug evaluation department said on October 16 that it has formed a board to oversee and advise on exclusivity determinations made by the department, aiming to improve clarity and consistency of those decisions.
According to the agency, the Center for Drug Evaluation and Research (CDER) exclusivity board will oversee certain exclusivity determinations, including whether and what type of exclusivity should be granted and the appropriate scope of grants. The board will focus on five-year new chemical entity exclusivity, granted to a drug whose active ingredient has never before been approved by the FDA; three-year new clinical study exclusivity for drugs whose approval relies on new clinical studies conducted or funded by the sponsor; and advice on exclusivity for biological products. It will not review other types of exclusivity.
The FDA said exclusivity rewards innovation by giving newly approved drugs a period of market protection before lower-cost generic competitors enter the market. The board may also evaluate and make recommendations regarding CDER's policies and practices relating to exclusivity, and maintain records of exclusivity determinations. (GSM, via Reuters)
Published by GSM · USA (original Chinese edition)
Photo: FDA白橡树园区64号楼外观 / Exterior of FDA Building 64 at the White Oak campus. Photo: FDA via Wikimedia Commons, Public domain.
- 2026-10-17FDA Sets Up Exclusivity Board to Oversee Drug Exclusivity Determinations
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