Nota Bene Episode 71: Shifting Regulatory Landscapes at the FDA: Cannabis, Vaping and Intelligent Medical Devices with Allison Fulton
In early January, the U.S. Court of Appeals for the Fifth Circuit, sitting en banc in Wages & White Lion Investments, L.L.C. v. U.S. Food & Drug Administration, held that the U.S. Food and Drug Administration’s (FDA)...more
No matter what the carping critics may claim about the shortcomings of the civil justice system, when Big Tobacco, Big Pharma, and big organizations exploit and harm the vulnerable, lawsuits and what follows may provide a...more
2019 ushered in numerous changes and new initiatives at the U.S. Food and Drug Administration (FDA). From the increasing popularity of cannabis use to the rapidly evolving nature of artificial intelligence in medical devices,...more
Food/Dietary Supplements - FDA and CDC Announced the End of a Salmonella Outbreak in Fresh Fruit – The Food & Drug Administration (FDA) completed its investigation into an outbreak of illnesses caused by Salmonella that...more
Push to end surprise medical billing - The Senate Finance Committee heard from providers and health insurers on S.309, a bill that prohibits certain provisions in contracts between health insurers and health care...more
The FDA actions that dominated 2019 demonstrated a shifting regulatory landscape for certain product types, such as e-cigarettes, foods and supplements containing cannabidiol (CBD), and digital health / machine learning...more
Tens of millions of Americans may have been startled in recent days by the much-publicized pulling from the shelves of widely used drugs like ranitidine (aka Zantac), an over-the-counter heartburn remedy, and select lots of...more
Food/Dietary Supplements - FDA Releases Report on Foodborne Illnesses – The FDA posted a report titled “Foodborne illness source attribution estimates for 2017 for Salmonella, Escherichia coli O157, Listeria monocytogenes,...more
There seems to be a never-ending outbreak of a certain kind of pathology in the United States. Big Pharma has it and spreads it around, a lot. So, too, do public health figures. Let’s call this scourge what it is —...more