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Home > Newsletters > Washington Drug Letter > CDER to Standardize REMS Under PDUFA V, Issue Guidance

Washington Drug Letter

Oct. 29, 2012 | Vol. 44 No. 43

CDER to Standardize REMS Under PDUFA V, Issue Guidance

CDER plans to standardize REMS development to make the safety tools more effective and less burdensome for drugmakers.

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