Off-Label Communications

While the FDA has had a long-standing policy of permitting drug, biologics, and medical device companies to respond to unsolicited requests for information about off-label use of their products, there has been significant discussion over what constitutes "unsolicited" in this context.

22 minute read June 27, 2012 at 11:16 AM
By
Areta L. Kupchyk And And Tracey B. Ehlers
Off-Label Communications

While the FDA has had a long-standing policy of permitting drug, biologics, and medical device companies to respond to unsolicited requests for information about off-label use of their products, there has been significant discussion over what constitutes “unsolicited” in this context.

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