WASHINGTON (CN) - The FDA plans to require that prescription drug television or radio advertisements have a side-effect statement that is clear, conspicuous and neutral.
Under the proposed regulation, the language of the ads must be understandable, easily readable and clearly articulated. Distracting representations (including statements, text, images or sounds) would not be allowed.
If this statement minimizes the major side effects and contraindications or is omitted, the drug could be considered misbranded.
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