Alexander Gaffney from raps.org has published an article on the newly released FDA guidance Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices addressing how companies can use scientific literature to promote its products. Practices using certain literature can blur the line between marketing the products and protected commercial free speech. The guidance is a revision of the 2009 guidance that was criticized for restricting life science companies’ ability to promote public health. In the new guidance FDA will be looking at science not promotion as the emphasis. To review the guidance on FDA’s website, click here, and to read Gaffney’s full article click here.
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