January 18, 2012

FDA Proposes a Restrictive Framework for Regulating Requests for Medical Product Information

Arnold & Porter Advisory

On December 30, 2011, the US Food and Drug Administration (FDA) released for public comment a draft guidance titled, "Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices" (Draft Guidance). The Draft Guidance provides FDA's nonbinding positions on how human and animal drug and medical device manufacturers should respond to unsolicited requests for information about unapproved or uncleared uses (off-label uses) of FDA-regulated products.


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