New FDA Board to Handle Exclusivity Decisions

Published Online: Friday, December 14, 2012
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A board within the FDA’s Center for Drug and Evaluation and Research (CDER) is intended to help the agency make consistent decisions on marketing exclusivity periods, according to an announcement on FDA.gov.

Although the CDER Exclusivity Board will not handle 180-day generic drug exclusivity, it will focus on exclusivity for new chemical entities, new clinical trials, and biologic products. Its primary focus is clarity and consistency, but it will not make recommendations in all cases, the FDA stated.

In addition, it is expected to collaborate with offices within the FDA that handle generic, pediatric, or orphan disease exclusivity, though those areas are not a primary focus.

Although it was only recently announced, the board began making decisions in April 2012, and typically meets once to twice per month.

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