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This video is Part 3 of a 9-Part Series excerpted from an Expert Mentor Session held by Michael H. Cohen, JD and Dr. Sunny Smith, MD on July 3rd, 2020.

The CMS and HHA are proposing new rules, such as the Patients over Paperwork Initiative, where the focus of Stark and AKS will be on value-based arrangements

This video is Part 2 of a 9-Part Series excerpted from an Expert Mentor Session held by Michael H. Cohen, JD and Dr. Sunny Smith, MD on July 3rd, 2020.

What is it that you want to get out of talking to a healthcare lawyer, an FDA lawyer or really any lawyer?

FDA and FTC warning letters continue to find violations of the FD&C Act when companies boast their products can cure or treat diseases such as COVID-19.

This video is Part 1 of a 9-Part Series excerpted from an Expert Mentor Session held by Michael H. Cohen, JD and Dr. Sunny Smith, MD on July 3rd, 2020.

A federal judge confirmed that the FDA has the right to regulate for-profit stem-cell therapy treatments. Autologous treatments may require FDA approval as drugs.

In today’s video, we discuss what are the minimum number of times per year and that a physician must see a patient, in-person, prior to treating the patient via telehealth?

FDA might classify your cosmetics product as a new drug if you make disease claims for your cosmetics product. FDA also requires that you substantiate your claims and have safe ingredients