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

Resumo

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Medical Product Communications That Are Consistent With the FDA-Required Labeling-- Questions and Answers." This 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 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 guidance to explain FDA's current thinking on commonly asked questions regarding such communications to provide clarity for firms. FDA is also announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.