A Word Here, A Word There: IND Investigator Tweaks Blog After US FDA Untitled Letter
OPDP's first 2019 letter cites problematic claims about an investigational PET drug; investigator's response was to adjust verb tenses and other wording in the blog post.
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Kowa Pharmaceuticals' patient testimonials implying switch from statins to Livalo will reduce drug side effects are misleading, untitled letter says.
‘Untitled’ letter is FDA's third in the past eighteen months to target promotions for women’s health products. In the case of advertisement for CooperSurgical's copper-containing intrauterine device, which is regulated as a drug, the agency took issue with distracting visuals and reliance on superimposed text.
Agency says superimposed text about risks and efficacy is overshadowed by "attention-grabbing before-and-after photographs" of patients treated with the seborrheic keratoses treatment.