Court upholds FDA’s legal authority to regulate stem cell therapies

FDA survived a legal challenge to its authority to regulate stem cells as drugs, in a landmark decision by the U.S. District Court of Appeals for the DC Circuit. FDA had cited Regenerative [...]

FDA proposes updates to Nutrition Facts label on food packages

The U.S. Food and Drug Administration today proposed to update the Nutrition Facts label for packaged foods to reflect the latest scientific information.

The Future of Medicine: From Physical to Online to Mobile to Wearable to Implantable

Just as the silicon "ink" dried on Telemedicine: The Future of Medicine, someone, somewhere, pronounced that there is a future for medicine beyond the future. This was no sweat for me, since I'm [...]

FDA exerts authority over medical devices with genomics

FDA flexed its jurisdictional muscle by warning 23andMe that its marketing of the 23andMe saliva test kit and personal genome service without marketing clearance or approval violated that federal [...]

Ancient Wisdom & Modern Technology: Legal Issues in Online Health, Mobile Health, E-Health, and Future Medicine

Healthcare and FDA lawyer Michael H. Cohen spoke on "Ancient Wisdom & Modern Technology" on ExitCoach Radio. Today, there are many healthcare and wellness related businesses popping up

FDA Cybersecurity Plan Adds to Mobile App Developer FDA Compliance Burden

The FDA now requires that mobile app developers create a cyber security plan and submit it to the FDA along with their mobile medical app / medical device submission.

Michael H. Cohen Speaking on FDA & Related Legal Issues in Online Health Ventures

Attorney Michael H. Cohen speaks on "FDA & Related Legal Issues in Online Health Ventures" at a prominent LA law firm's Restaurant, Food & Beverage Group on July 9.

Healthcare lawyer Michael H Cohen quoted in the Tan Sheet on FDA Preemption Lawsuits

Healthcare lawyer Michael H Cohen was quoted in the Tan Sheet on an article about FDA Preemption Lawsuits involving Monster beverages.

FTC Blasts POM for Disease Claims, Highlighting Substantation Issues

The FTC blasted POM Wonderful for making deceptive and unsupported advertising claims regarding their pomegranate products.

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