FDA Issues Off-Label Information Guidelines for Industry

The FDA issued draft guidelines that would allow drug and device makers to provide information on off-label uses, but only if the request for information is unsolicited, or one not initiated by the drug or device maker or distributor, according to an FDA report.

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Drug and device makers are prohibited from promoting drugs or devices for uses not approved by the FDA, but once a drug or device is approved by the FDA, it can be used by healthcare professionals for other uses. The FDA said the emergence of online media now allows the public to research products on sites that might not provide accurate information. For this reason, the FDA will allow drug and device makers to respond to public and nonpublic requests for information.

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