FDA & FTC Law

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 FDA's final Guidance for Industry and FDA staff on mobile medical apps continues to constrain industry development of new health apps. Like the draft mobile medical app FDA guidance, the [...]

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 [...]

Healthcare & FDA attorney Michael H Cohen spoke in Woodland Hills, California to the SoCal IP Law Group on "Our Designer Future: How FDA Legal Issues Shape Human Health–From Medical Devices to [...]

"Health Apps as Medical Devices: What It Means for Consumers" by healthcare, FDA & business lawyer Michael H Cohen was published by LegalZooom in its online legal headlines on Technology. The [...]

FDA Attorney Michael H. Cohen speaks on FDA Legal Issues at the Ventura BioScience Incubator on October 17, 2013.The talk will focus on FDA regulation of cosmetics, dietary supplements, and [...]

The FDA's Mobile Medical App Guidance contains many nuanced definitions that determine whether your mobile app will likely be regulated by the FDA as a medical device.Recent clients have asked [...]

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.

FDA now requires a cyber security plan in your medical device submission. On June 14, 2013, FDA issued Draft Guidance on Content of Premarket Submissions for Management of Cybersecurity in [...]

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