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FDA Creates Exclusivity Board To Help Resolve Vexing Questions

 
• By Brenda Sandburg

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.

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Pink Sheet Podcast: Vaccine Review Political Interference, Missed Deadlines A Harbinger Of US FDA Problems?

 
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More from North America

How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 
• By Joseph Haas and Nielsen Hobbs

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US FDA Not Industry’s ‘Sock Puppet,’ Ultragenyx’s Emil Kakkis Says

 
• By Sue Sutter

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