REMS Format and Content: FDA Offers Draft Guidance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The US Food and Drug Administration (FDA) on Wednesday released updated recommendations in the form of a draft guidance for the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drugs and biologics.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Tags: REMS, REMS document, FDA draft guidance, GDUFA II