Responding to questions on off-label uses of medical devices and drugs without breaking the US rules on promoation

Kim Martin, Co-Chair of the firm’s Life Sciences Practice Group and a trial attorney with an emphasis on medical device and pharmaceutical products liability litigation, was published in the September 2012 issue of Scrip Regulatory Affairs. Ms. Martin’s article explains why companies are concerned by the Food and Drug Administration’s proposals on how they may respond to unsolicited requests for information on off-label uses of their products.

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