Society is driven by word-of-mouth endorsements. Likewise, it’s instinctive to share self-prescribed remedies that alleviate our various ailments. A colleague recommends ginger tea for a cold. A friend tells you how lavender essential oil helps with anxiety and insomnia. We habitually rely on such recommendations. However, a business making such…
On May 31, 2019 the FDA held a public hearing about cannabidiol (CBD) products. The day-long hearing saw comments and presentations from stakeholders ranging from nonprofit organizations like ASTM International to the Grocery Manufacturers Association, a food, beverage and consumer product trade association. Corporate entities in the cannabis industry also…
The cybersecurity ramifications of the Internet of Things (IoT) are perhaps nowhere more crucial—potentially a matter of life and death, in fact—than in the realm of medical devices. Until recent times, a potential hack of the data-sharing that is a hallmark of the IoT raised far more privacy concerns than…
Colleague Caitlin Bloom Stulberg has recently released a thorough examination on FDA compliance in the realm of consumer-generated content. It’s an issue we discuss often and is becoming more prevalent as increased social media use blurs the line between manufacturer-promoted advertising and independent consumer opinions. The discussion investigates when consumer-generated…
When Kim Kardashian speaks, the FDA listens. Or, more precisely, when Kardashian, who has 46.8 million followers on Instagram, posts an enthusiastic endorsement—and advertisement—on the social media platform for Diclegis, a prescription drug for treating morning sickness, the agency takes notice (and gives it). In a letter to Duchesnay Inc., the…
On August 1, 2014, the Food and Drug Administration (FDA) released draft guidance that would exempt from premarket 510(k) review many low-risk medical devices–including certain mobile applications that can convert a cell phone into a medical device, such as a thermometer or a stethoscope. Although the guidance is not yet…
The Federation of State Medical Boards recently adopted Model Policy Guidelines for use of social media in medical practice. The use of social media by medical practitioners and the number of mobile medical and wellness applications continues to increase. These factors are transforming certain aspects of the doctor patient relationship.…