FDA issues draft guidance to better medical product labeling
The U.S. health regulator issued draft guidance, recommending ways to communicate promotional materials and additional information that is not on the label of medical products.

The U.S. Food and Drug Administration typically determines what information goes on the labels of medical drugs and devices, after evaluating whether the product is safe and effective for the proposed indication.

Drugmakers have long wanted to communicate supplementary information that isn't on the label, but which concerns the cleared use of the product. (bit.ly/2jz9dRh)

However, the FDA said it does not consider the supplementary information that is consistent with the FDA-required labeling guidelines alone to be evidence of a new intended use....

http://in.reuters.com/article/us-fda-draft-guidance-idINKBN15237U
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