In today’s video, we discuss how FDA can find that your dietary supplement or cosmetic deserves to be regulated as a “drug,” which means you can’t sell your product unless you get premarket, New [...]
In today’s video, we discuss how FDA’s Intended Use Doctrine really shapes the potential market for your dietary supplement claims. We’ll also explain how the Intended Use Doctrine affects your [...]
In today’s video, we return to the topic of medical devices to address a more specific question: are apps medical devices? If you’ve seen our previous video on medical devices, you’ll recall the [...]
In today’s video, we discuss medical devices and the basic information you need to know about them. Many of our clients have asked us how they are supposed to know whether something is considered [...]
In today’s video, I’m going to talk about the gap between the law and what you want to accomplish as a healthcare startup or a health and wellness practice or a healthcare company.
California, New York, and doctors everywhere need to understand what state laws apply to telemedicine including who can offer telemedicine, what consents from the patient are needed, and whether [...]
In today’s video, I’m going to speak extemporaneously about Stark Law and Anti-Kickback Law. Why? Because Stark and anti-kickback and fee splitting, also known generally as fraud and abuse, these [...]