Pharmaceutical Promotion Compliance: Avoiding the Common Mistakes

There are certain key questions to keep in mind when creating promotional materials for prescription drugs and reviewing these materials for regulatory compliance:
 
• Is the content truthful and not misleading?
• Does the content present a full and balanced disclosure of risks and material facts?
• Are the product claims being made in the promotional material explicitly included within the indication approved by the FDA?
• Are the product claims supported by substantial evidence?
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Amarin v. FDA: Predicting the Future of Off-Label Promotion


If folks in your marketing department seem unduly cheerful despite the end of summer, they may be experiencing a case of Amarin-induced euphoria. But, while your colleagues are feeling euphoric, you, as a compliance professional, may now feel acute off-label promotion anxiety. What may the future hold in a post-Amarin world?
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Cannabis Packaging and Labeling: Challenges with Intrastate Compliance


Cannabis Today
 
2014 was a monumental year for the US legal cannabis market. 25 states and Washington D.C. now have some measure of medical or adult-use legislation, creating a market that is estimated to grow to over $10BN by 2018 (Arcview Market Research, 2014).
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