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#thefdalawblog #FDA #OPDP #ADPROMO To view or add a comment, sign in FDA just dropped a wave of Untitled and Warning Letters on prescription drug promotion, calling out lifestyle imagery, selective QoL claims, and even distracting visuals

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FDA Commissioner Scott Gottlieb explained in a statement that, This action is based on the imminent health risk posed by the contamination of this product with salmonella, and the refusal of this company to voluntarily act to protect its customers and issue a recall, despite our repeated requests and actions. In addition to the mandatory recall order against Triangle Pharmanaturals involving at least 26 products, there have been several voluntary recalls associated with the kratom salmonella outbreak and several by companies whose kratom products were unrelated to the salmonella outbreak

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