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FDA Exploring Whether Public Shaming Can Stop REMS Abuses

 
• By Derrick Gingery

Commissioner Gottlieb says agency is considering publicizing letters it has written to brand companies indicating it would not violate a REMS to sell a generic company samples for testing.

FDA entrance sign 2016

The US FDA may resort to using its bully pulpit to lessen REMS abuses that prevent generic entry.

Agency letters to brand companies indicating it is acceptable under a Risk Evaluation and Mitigation Strategy (REMS) to sell samples to a generic company for testing may be made public,...

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