The Latest On Off-Label Responses

Law360, New York (January 5, 2012, 2:50 PM EST) -- On Dec. 27, 2011, the U.S. Food and Drug Administration released a draft guidance on how pharmaceutical and medical device manufacturers should respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use related to their FDA-approved or -cleared products.[1]

The draft guidance largely reaffirms the agency’s view that companies can respond to unsolicited requests for information about FDA-regulated products by providing truthful, nonmisleading scientific or medical information that is responsive to the specific request, even if such information relates to an...
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