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    FDA Enforcement Trends for Broadcast Advertisements

    This article presents recent FDA enforcement trends related to broadcast advertisements and explains how regulatory professionals can approach the review and approval of promotional materials. The article also provides a review of relevant FDA authorities and guidance, as well as practical takeaways for industry with a focus on product ads appearing on TV or YouTube that may distract viewers from important risk information. Introduction From January 2016 through Augus...
  • FDA Using Twitter, Telenovelas and Translations to Reach Non-English Speakers

    If you're reading this article, chances are good you take something for granted every day: your ability to read. But even beyond that, the fact that you're reading Regulatory Focus means you're probably fluent in English and well-versed in medical terminology. Many Americans, though, can't read, can't read or speak English, or can't read or speak English well enough to understand the medical terminology that is necessary to interpret the labels on medical products like...
  • Can a YouTube Video be a Medical Device? The Curious Case of Videos to Treat Insomnia

    Can a YouTube video be a medical device, and should the US Food and Drug Administration (FDA) be cracking down on certain videos on the Google-owned network? Background As reported by ABC , The Huffington Post and other news outlets, practitioners of "Autonomous Sensory Meridian Response" (ASMR) have been taking to YouTube in recent years. The practice focuses on relaxing noises, which practitioners claim cause a "relaxing" and "tingling" sensation in the body...