5 Key Takeaways From the FDA’s Draft Guidance On Presenting Risk/Benefit With Character Limitations

5 Key Takeaways From the FDA’s Draft Guidance On Presenting Risk/Benefit With Character Limitations

The FDA recently released two documents providing draft guidance on the utilization of particular aspects of social media.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5 Key Takeaways From the FDA’s Draft Guidance On Correcting Independent Third-Party Misinformation

5 Key Takeaways From the FDA’s Draft Guidance On Correcting Independent Third-Party Misinformation

  Yesterday the FDA released not one, but two documents providing draft guidance on the utilization of particular aspects of social media, entitled Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation about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…

For Pharma, All Of This Has Happened Before

For Pharma, All Of This Has Happened Before

As someone who grew up with the internet and made it my career I can tell you, the era we’re in right now looks and smells oddly familiar. How? Well ‘back in my day’ the Internet was just a thing. Conceptual. New. No one understood it but everyone was talking about it. Consumers played with it. Brands tried to use it. The media talked about it endlessly. Like with most new things, objectives for success were often poorly defined, but money, gobs and gobs of money were thrown at it….

FDA’s Latest “Guidance” About Mobile Apps Is Much Ado About Nothing

FDA’s Latest “Guidance” About Mobile Apps Is Much Ado About Nothing

If you spend any amount of time in this business, you no doubt woke up this morning with your Twitter feed loaded with “What the FDA’s Latest Letter Teaches Us About Mobile” tweets. I did. Let me boil it down for you. Nothing. It teaches us nothing. No, I take that back. If you happen to be the one person left in the universe that doesn’t understand that in order to market any kind of diagnostic device in the United States, it first must be submitted and gain approval from…