WHEN: Thursday, February 26, 2015
TIME: 12:00pm – 1:30pm EST
To register for this webinar, please click here.
Please join us for a complimentary webinar addressing wireless health regulatory issues. This session will discuss recent trends in health technology regulation; including Food and Drug Administration (FDA) developments, Federal Communications Commission (FCC) requirements, wireless technology and communication issues, mobile applications, decision support and other Health IT challenges, and privacy and cyber security considerations.
This session is relevant to tech companies, communications companies, entrepreneurs, and developers that are entering the wireless health technologies space or considering acquiring mobile health assets.
Topics … Continue Reading
When FDA published its draft guidance Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices in June 2014, I, like many others with an interest in pharmaceutical and medical device promotion, believed that the issue of social media promotion of drugs and medical devices was largely settled. Even with the limited concessions offered by FDA to reduce the traditional risk disclosure requirements, absent a substantial shift in FDA’s position, Twitter was not going to be a medium that drug and device companies could use to effectively promote their products. Sure, companies … Continue Reading
FDA published the long awaited draft guidance on wellness products last Friday. The guidance is a positive step forward for industry in that it proposes that certain general wellness products will not be subject to FDA regulation.
The draft guidance clarifies that FDA does not intend to enforce its regulations against products that are “low risk” and are intended to:
… Continue Reading
- Maintain or encourage health without reference to a disease or condition (e.g. weight, fitness, stress) or
- Help users live well with or reduce risks of chronic conditions, where it is well accepted that a healthy lifestyle may reduce the risk