Medical Product Communications That Are Consistent With the Food and Drug Administration-Required Labeling-Questions and Answers; Draft Guidance for Industry; Availability

概要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Medical Product Communications That Are Consistent With the FDA-Required Labeling--Questions and Answers." This draft guidance provides information for manufacturers, packers, and distributors and their representatives (collectively "firms") of drugs and medical devices for humans, including those that are licensed as biological products, and animal drugs (collectively "medical products"), about how FDA evaluates their medical product communications, including their promotional materials, that present information that is not contained in the FDA-required labeling for the product but that may be consistent with the FDA-required labeling for the product. The Agency is issuing this draft guidance to explain FDA's current thinking on commonly asked questions regarding such communications in order to provide clarity for firms.