FDA issues draft guidance concerning unsolicited requests for off-label information and seeks comments concerning scientific exchange of information

On December 28, 2011, the U.S. Food and Drug Administration (FDA or "the Agency") published a Federal Register notice requesting comments and information1 to assist with its evaluation of FDA policies pertaining to communications and activities related to unapproved ("off-label") uses of marketed products, as well as those related to products that are not legally marketed in the United States for any use. In particular, the Agency seeks to obtain comments and information related to "scientific exchange."

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