FDA Outlines Steps For Changing Drug Safety Controls

Law360, New York (April 6, 2015, 2:32 PM EDT) -- The U.S. Food and Drug Administration on Monday explained how changes to the so-called risk evaluation and mitigation strategies of prescription drugs should be reported, its latest effort to clarify muddled policies on warnings and restrictions for higher-risk products.

The FDA's action came in guidance that was prompted by the 2012 user fee law, which included provisions aimed at streamlining changes to REMS — risk-management plans that warn of serious side effects and restrict how drugs are distributed, prescribed or dispensed. Changes are common, and in fact, the FDA has lifted about two-thirds of the 200 REMS that it initially required....

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