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REMS Website Will Name, Not Shame, Potential Abusers – Gottlieb

 
• By Michael Cipriano

US FDA will list number of inquiries about acquiring samples for generic drug development, and also whether FDA sends letters to brand companies telling them it is safe to provide the generic sponsor with the samples. 

FDA entrance sign 2016

The US FDA is preparing to launch its website to publish the names of drug companies suspected of using risk evaluation and mitigation strategies (REMS) to stonewall generic sponsor access to samples, in a move Commissioner Scott Gottlieb insists is not meant to publicly shame the brand firms.

The website, which could be launched as early as May 17, will specifically contain the amount of "inquiries" there are for particular drugs, and also whether "safety determination letters" are...

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