The Murky Waters Of Off-Label Liability

Law360, New York (December 1, 2011, 5:59 PM EST) -- Physicians frequently prescribe drugs for a use that is different than what has been approved by the U.S. Food & Drug Administration. The package insert that is provided with each drug approved by the FDA sets forth the specific uses for which that drug has been approved.

Under the law, the FDA allows physicians to use approved drugs in any manner which the physicians deem appropriate, even if the drug has not been approved for that use. The use of drugs in this way is commonly...
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