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Companies Marketing CBD Products Be Warned: FDA Is Watching

USA - November 20 2017 The US Food and Drug Administration recently issued warning letters to four companies - Stanley Brothers Social Enterprises LLC, Greenroads Health…

Brian J. Malkin, James R. Ravitz

FDA Announces “New” Framework to Regulate Stem Cell Therapies and Regenerative Medicine

USA - September 8 2017 Last week, FDA Commissioner Gottlieb issued a statement describing the Agency’s “new” policy for regulating stem cell therapies and regenerative…

Naomi J. L. Halpern, James R. Ravitz

FDA Requires Pharma Companies to Certify Drug Listing Info

USA - October 6 2017 In August 2016, the Food and Drug Administration issued a final rule to update and clarify the agency’s drug registration and listing regulations. The…

Stephanie Trunk

Recent Drug Company Settlement Highlights Unique Theory of False Claims Act Liability: Failure to Follow Current Good Manufacturing Practices

USA - February 16 2017 Last month, Baxter International Inc. and Baxter Healthcare Corporation (collectively “Baxter”) settled a qui tam False Claims Act (FCA) case with…

Stephanie Trunk

DEA Considers Rescheduling Marijuana

USA - April 18 2016 The US Drug Enforcement Administration recently announced that it is evaluating whether to downgrade the classification of marijuana under the…

James H. Hartten, James R. Ravitz