Home » Generic Drugmakers Get U.S. Guidance on Removing REMS
Generic Drugmakers Get U.S. Guidance on Removing REMS
December 9, 2011
U.S. Food and Drug Administration (FDA) final guidance on distribution of medication guides allows generic drugmakers to submit a changes-being-effected supplement to eliminate having to adopt a risk evaluation and mitigation strategy (REMS) if the REMS for the brand drug has been removed and includes only a medication guide.
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