Websites, medical meetings, television talk shows, trade shows . . . wherever your products are being mentioned, chances are good the FDA is watching and looking for violations of the rules covering promotions.
And with the agency cranking out three more social media guidances in 2014, you can expect even more challenges in the way the FDA evaluates promotions in the months ahead.
Now’s the time to take stock of your promotional review practices and see if they’re really covering all the places they need to – even those you might least expect. And what you can do about it if they’re not.
When the FDA reviews promotions it’s not looking at how the information is being distributed. Rather, it looks at what information is being distributed. The agency focuses on violations in four general areas that could occur in digital, nontraditional and, of course, standard promotions. The four areas are:
Within these four broad categories, the FDA is highlighting some underlying themes, like preapproval promotion. And it's taking a closer look at products that have a black box warning — and oncology products — which have a greater safety risk.
With these enforcement trends in mind, the new report It’s the Message, Not the Medium: Managing FDA Promotional Compliance Beyond Traditional Media will help you take a hard look at your corporate communications and your formal and informal promotional activities, with an eye toward eliminating your risk of noncompliance.
With this report, you will learn:
With It’s the Message, Not the Medium: Managing FDA Promotional Compliance Beyond Traditional Media, you'll gain a clear understanding of what the FDA is watching NOW — and how to avoid enforcement action in the future.
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