The pharma implications of the FDA’s policy on low risk devices

The pharma implications of the FDA’s policy on low risk devices

On January 19th, the FDA released draft guidance about wearables dated January 20th, proving not only do they have access to a time machine, but they are totally willing to rub our noses in it. The document, which you can download here, relates to the FDA’s policy on what it deems as “low risk devices,” i.e., wearables. Low risk devices, by the FDA’s definition, are those that, “involve claims about sustaining or offering general improvement to conditions and functions associated with a general state of health that do not make any…

5 Key Takeaways From the FDA’s Draft Guidance On Presenting Risk/Benefit With Character Limitations

5 Key Takeaways From the FDA’s Draft Guidance On Presenting Risk/Benefit With Character Limitations

The FDA recently released two documents providing draft guidance on the utilization of particular aspects of social media. The first was entitled, Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation about prescription Drugs and Medical Devices. The second was entitled, Internet/Social Media Limitations – Presenting Risk And Benefit Information for Prescription Drugs and Medical Devices, which is the focus of this post. While not as clear or concise as their other previous guidance releases, there are 5 key things digital marketers need to be aware of, some of which potentially muddying the…

5 Key Takeaways From the FDA’s Draft Guidance On Correcting Independent Third-Party Misinformation

5 Key Takeaways From the FDA’s Draft Guidance On Correcting Independent Third-Party Misinformation

  Yesterday the FDA released not one, but two documents providing draft guidance on the utilization of particular aspects of social media, entitled Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation about prescription Drugs and Medical Devices, which is the focus of this post. The other, Internet/Social Media Limitations – Presenting Risk And Benefit Information for Prescription Drugs and Medical Devices, can be read about in another posting. In keeping with the tradition of most of these releases, these guidelines are drafts and may change over time, but in reading them there are 5…

Is It Time For Pharma To Give Up The Social Media Ghost?

Is It Time For Pharma To Give Up The Social Media Ghost?

Social media has been a big focus for pharma marketers for a while now. By my count, at least 30-45% of ePharma’s agenda from the 2014 NY conference was focused on the subject, and there is a whole cottage industry of other conferences specifically for social media fin the pharma industry. If you spend any time following pharma folks on Twitter, you can find tons of tweets on the subject and create whole feeds for hashtags like #socpharm, #hcsm, #pharmsm, etc. I say it’s time to move on. You read…