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Brand, Generic Disputes Over Access Move Beyond REMS Restrictions

 
• By Sue Sutter

Generic companies say innovators are using voluntary restricted distribution programs to prevent them from obtaining reference drugs for bioequivalence testing; a July hearing is set in a dispute involving Actelion’s Gaucher disease drug Zavesca, which is not subject to a Risk Evaluation and Mitigation Strategy.

The growing tension between the innovator and generic drug industries over access to branded products for bioequivalence testing is moving beyond the framework of restricted distribution programs under Risk Evaluation and Mitigation Strategies.

Legal disputes are on the rise in which generic drug manufacturers assert the brand company has used a voluntary restricted...

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• By Bridget Silverman

With a 25-27 June meeting looming, HHS Secretary Robert F. Kennedy Jr. can fill all 17 spots on the CDC's Advisory Committee on Immunization Practices with people he says will "exercise independent judgment."

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

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