FDA Proposals For Studying Internet Promotions Raise Concerns
FDA should not delay draft guidance on Internet and social media promotional activities while it studies how consumer understanding of a drug’s safety and efficacy is affected by the techniques used to present information on branded websites, according to comments on the proposed studies.
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Typography and graphics which highlight benefits but not risks makes a print ad for Xarelto to treat atrial fibrillation misleading, FDA tells Johnson & Johnson in an untitled letter.
Women who survived a rare cardiovascular event banded together online and approached Mayo Clinic investigators with a research agenda, and AstraZeneca is using a YouTube video to find Internet-savvy patients who might be reluctant to reach out about their condition.
The agency will examine how various aspects of Internet-based ads affect consumer understanding of product safety and efficacy in four separate studies.