Generic Exclusivity Awards Process Might Go Public

FDA wants to know whether 180-day exclusivity should be revealed up front; question is one of many on ANDA reviews to be considered at September public hearing.

FDA will consider making its process for determining generic drug exclusivity awards public, an idea that would increase agency transparency and also continue the formalization of the agency’s generic drug system.

During a public hearing that will be used to set fiscal year 2015 policy priorities for the generic drug user...

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