The US Food and Drug Administration’s final guidance on how to present quantitative information about a prescription drug’s efficacy and risks in promotional communications is virtually identical to the draft guidance issued in 2018. But it includes an additional example advising sponsors not to use the modifier “only” to avoid characterizing a risk as insignificant.
Rx Drug Ads Should Not Characterize Probability Of Risk As Insignificant, FDA Emphasizes
Agency’s final guidance on presenting quantitative efficacy and risk information in direct-to-consumer advertisements includes an additional example, which specifies risk should not be characterized in a way that suggests it is not important.
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