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Drug Promotion Enforcement Letters: 19 Buzzwords OPDP Keys On During Promotional Reviews
When just one wrong word can derail an entire drug marketing campaign, you need to know what that one word is. Get the red flags out of your marketing messages.
An analysis of OPDP enforcement letters clearly shows 19 words and phrases you shouldn’t use in your prescription drug advertising. But, you won’t find these words or phrases spelled out on the FDA website – or anywhere, for that matter.
Plus, there’s a variety of study designs that failed OPDP’s “substantial evidence” threshold to support safety and efficacy claims. Could you be using these in your promotions right now?
Washington lawyer Julie Tibbets has combed through recent enforcement letters and drawn up the buzzwords and study designs. Now she’s ready to share it – with YOU.
In over 90 highly informative minutes, Ms. Tibbets shows just what the FDA is looking for in your branding, advertising and promotion. Using actual enforcement-letter texts to back up her presentation, she identifies current trends and shares best practices to help you avoid receiving such a letter. You’ll discover –
You’re sure to think of questions during Ms. Tibbets’ presentation. No need to save them up though. Simply email them in, in real time, for full responses by the time the session ends.
It’d be well worth your time and trouble to fly to Washington for regulatory insights such as these. Luckily there’s no need to incur the expense or hassle. This session comes to you, via the screen sitting on your own desktop.
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Julie Tibbets is a partner in the Food, Drug & Device/FDA Group at Alston & Bird LLP. Her practice focuses on regulatory risks associated with product positioning – branding, advertising and promotion – especially as they Rx drug and device labeling and advertising, sales training, interactions with health care professionals, continuing medical education, social media, Sunshine Act compliance and medical affairs. She was named a 2013 and 2014 FDA-practice "Rising Star" by Super Lawyers Magazine.
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