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

Executive Summary

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. 

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Generic Company Disclosure Could Be A 'Speedbump' Against Misuse Of US FDA Access Inquiry List

Generic companies might get more transparency than they bargained for if there is misuse of the public list of reference drugs they say they have trouble obtaining; at BIO annual meeting, FDA Commissioner Gottlieb also suggests VA procurement of brand drugs as possible alternative if innovators continue to hinder access for bioequivalence testing.


Generic Company Disclosure Could Be A 'Speedbump' Against Misuse Of US FDA Access Inquiry List

Generic companies might get more transparency than they bargained for if there is misuse of the public list of reference drugs they say they have trouble obtaining; at BIO annual meeting, FDA Commissioner Gottlieb also suggests VA procurement of brand drugs as possible alternative if innovators continue to hinder access for bioequivalence testing.


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