A product’s regulatory history and competitive landscape may factor into the US Food and Drug Administration’s evaluation of whether drug promotions are consistent with labeling, but false and misleading efficacy problems remain a focus.
Key Takeaways
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All six OPDP enforcement letters issued in the past year have cited false or misleading claims or misrepresentations about efficacy, with sponsors running afoul of the six year-old CFL guidance.
Legal and regulatory experts at at recent DIA advertising and promotion conference reviewed some of the FDA’s enforcement actions under...
