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On January 19th, the FDA released draft guidance about wearables dated January 20th, proving not only do they have access to a time machine, but they are totally willing to rub our noses in it.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5 Key Takeaways From The FDA’s Draft Guidance on Interactive Promotional Media

5 Key Takeaways From The FDA’s Draft Guidance on Interactive Promotional Media

This week, the FDA Quietly released it’s densely titled “Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.” You can download and read them from here. In keeping with the tradition of most of these edicts, these guidelines are drafts and may change over time, but in reading them there are 5 key things digital marketers need to be aware of. 1. If you own it, balance it.
 This may seem like an no-brainer, but it’s almost always…

Creating An App-Panic

Creating An App-Panic

iMedicalApps.com published an article detailing Apple’s ‘new’ development policy which will reject any app that includes dosing information for a medicine. Normally I wouldn’t comment on an article from another site in this much depth, but given the way headlines suddenly become ‘insights’ in this business, I thought it would be helpful to clarify a few things. The article starts with an ominous headline “Apple is now rejecting new medical apps that include drug dosages.” Apple is not doing this across the board. One or two devs got rejected. Which…