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REMS Format and Content: FDA Offers Draft Guidance By Zachary Brennan - Published 11 October 2017

The US Food and Drug Administration (FDA) on Wednesday released updated recommendations in the form of a draft guidance for the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drugs and biologics.

Categories: News, US, FDA, Drugs, Labeling, Regulatory intelligence, Regulatory strategy

Tags: REMS, REMS document, FDA draft guidance, GDUFA II