FDA Sets Up Exclusivity Board to Oversee Drug Exclusivity Determinations
WASHINGTON — The U.S. Food and Drug Administration said on Friday, October 16, that it has set up an exclusivity board within its Center for Drug Evaluation and Research (CDER) to oversee certain determinations on drug market exclusivity, including whether exclusivity applies and what type and scope it takes, according to Reuters.
The board's main focus will be two of the most common forms of exclusivity: the five-year exclusivity granted to new chemical entities and the three-year exclusivity tied to new clinical investigations. It will also advise on exclusivity for biological products, but will not review other types of exclusivity determinations.
Marketing exclusivity is a period of market protection that runs independently of patents. While it lasts, the FDA cannot approve competing generic versions of a drug, so exclusivity rulings directly shape competition and pricing between brand-name and generic medicines. Beyond individual cases, the board may also evaluate CDER's exclusivity policies and practices and recommend changes, and will maintain records of determinations. (GSM, via Reuters)
Published by GSM · USA (original Chinese edition)
Photo: 美国食品药品监督管理局总部大楼入口（FDA官方照片，公共领域）｜Entrance of FDA headquarters (U.S. Food and Drug Administration photo, public domain)
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- 2026-10-17FDA Sets Up Board to Oversee Drug Exclusivity Determinations
