FDA's Drug Ad Rule And Learned Intermediary Doctrine
The proposed rule set standards for determining whether DTC ads present warnings in a “clear, conspicuous and neutral manner.” The new standards are highly subjective, and would require interpretation and application to each unique DTC ad. Thus, the new standards could create challenges for pharmaceutical companies in how they develop and approve DTC ads.
Aside from the costs to bring...
Already a subscriber? Click here to login