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Health Care & Hospital Law

Jan. 21, 2012

Drugmakers look to FDA for guidance on off-label marketing

The FDA has only recently made an attempt to clarify its stance on what constitutes off-label marketing, the illegal promotion of drugs and medical devices for non-approved uses.


By Mandy Jackson


Daily Journal Staff Writer


Facing the loss of patent protection for their products, many pharmaceutical companies are exploring new uses for their drugs, even as federal prosecutors have stepped up enforcement of laws that prevent illegal promotion of unapproved uses.


Taken together, the two factors have converged to create a perfect storm for drug companies and medical device makers hoping to benefit patients and maximize pro...

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