Expert Mentor Session Part 7: Should I Use Legal Document Templates?

This video is Part 7 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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What Happens If You Make a Food with Hemp, Cannabis, or THC – Part One

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

Expert Mentor Session Part 6: Do I Need a State-Specific Lawyer for My Business?

This video is Part 6 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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FDA Issues Warning Letter to Company that Sells CBD Products Online and Through Social Media

FDA sends warning letter to a company because its website and social media accounts made claims about CBD products that suggest they are drugs or dietary supplements and were misbranded.

New HHS 21st Century Cures Act IT Rule – Part 2

These are two more of the non-fulfillment exceptions to the ONC rule. Another three fulfillment exceptions follow. The exceptions try to balance the ability of the developers and practitioners to [...]

New HHS 21st Century Cures Act IT Rule – Part 1

The Office of the National Coordinator for Health Information Technology (ONC), which is part of the Department of Health and Human Services, approved a final rule which implements certain [...]

Expert Mentor Session Part 5: Tips to Protect Intellectual Property

This video is Part 5 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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Expert Mentor Session Part 4: Business Exit Strategy

This video is Part 4 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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Why Medical Device Companies Need to Fear FDA Warning Letters

The FDA examines whether medical devices comply with the regulations of the Food, Drug, and Cosmetic Act. Two of the most common violations medical device companies are charged are adulteration [...]