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...
FDA Exploring Whether Public Shaming Can Stop REMS Abuses
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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.
Learn what's happening at the US FDA. On the go.
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