The US FDA has issued draft guidance, recommending ways to communicate promotional materials and additional information that is not on the label of medical products.
Drugmakers have long wanted to communicate supplementary information that isn’t on the label, but which concerns the cleared use of the product.
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.
The guidance is available for comment for about three months, after which the FDA will release its final determinations.
