Multistate Coaching Laws & Legal Challenges

In today’s video, we discuss healthcare legal compliance challenges that a healthcare startup might face when it ventures into digital healthcare, and advises its customers on healthcare and [...]


2021 Healthcare Trends

Most 2021 healthcare trends include new technology such as genome editing, mRNA messaging, artificial intelligence, predictive analytics, and advanced EHR systems.


What Happens If You Make Cosmetic, OTC Drug, or Dietary Supplement with Hemp, Cannabis, or THC – Part Two

Healthcare makers, distributors, and sellers must comply with FDA rules and warning letters for their cannabis, hemp, and THC products including foods, OTC drugs, cosmetics, and dietary supplements

Functional Medicine Telemedicine: How Do You Set It Up

Dr. Bob Smith came to our law firm, he was a hospital physician with 15 years’ experience. The hospital let go a lot of its staff, and Dr. Bob decided to open a telemedicine practice focusing on [...]

FDA Reviewing Moderna’s COVID-19 Vaccine

An Advisory Panel for the Food and Drug Administration is reviewing a request by Moderna for its COVID-19 vaccine. Moderna’s vaccine is expected to be distributed in the coming months.


FDA Approves Authorized Use of a COVID-19 Test Product

FDA granted emergency use authorization to Lucira Health Inc. for a COVID-19 self-testing kit. The EUA has numerous conditions that the manufacturer must meet.

FDA Issues Emergency Use Authorization for Pfizer COVID-19 Vaccine

FDA granted an Emergency Use Authorization to a COVID-19 vaccine developed by Pfizer, Inc. Doses of the vaccine have already been administered to health workers


Legal Risk Issues in Regenerative Medicine and Anti-Aging Medicine

As the population ages, health providers and health companies are developing and expanding their regenerative medicine and anti-aging practices. As with all healthcare services and products, [...]


The FDA Provides New Guidance on the “Minimal Manipulation and Homologous Use” of Cell and Tissue Products.

The FDA new guidelines on minimal manipulation include questions and answers. Meeting the minimal manipulation test can save companies a fortune in IND studies and clinical trial tests.

Expert Mentor Session Part 9: When Should You Consider Trademarking?

This video is Part 9 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.

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