Article: Proposed FDA Rule Relaxes Use of Off-Label Articles.(United States. Food and Drug Administration)

Byline: Donna Young, Washington Editor

The FDA is considering permitting drug and device makers to more broadly use published scientific and medical journal articles about unapproved, or off-label, uses when promoting their FDA-approved products to physicians.

While physicians are free to prescribe drugs and devices for off-label uses, manufacturers are banned from promoting their products for indications not approved by the FDA. However, the agency in a new draft guidance document issued Friday, proposed that firms under certain circumstances may distribute journal articles and other publications about the off-label uses of approved products.

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