FDA Creates Exclusivity Board To Help Resolve Vexing Questions

The board, housed within CDER, seeks to assure FDA makes consistent decisions on new chemical entity, new clinical trial and biologics exclusivity; FDA denied GSK’s request for NCE exclusivity for Veramyst and revoked Pfizer’s Torisel exclusivity.

FDA has quietly established a new review board within the Center for Drug Evaluation and Research – the CDER Exclusivity Board. Its goal is to help the agency make consistent findings on whether products should be granted periods of marketing exclusivity.

The focus of the board will be on five-year new chemical entity exclusivity, three-year new clinical trial exclusivity, and exclusivity...

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