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Generics Demand Stronger Proscriptions in REMS Compliance Letter Guidance

FDAnews Drug Daily Bulletin
Pharmaceuticals / Postmarket Safety / Submissions and Approvals
Generics Demand Stronger Proscriptions in REMS Compliance Letter Guidance

Generic drugmakers charge a December draft guidance doesn’t go far enough in enabling them to obtain bioequivalence testing batches for drugs protected by REMS product safety protocols.

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