Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased...more
When it comes to medical products — devices put in or substances put on our bodies — consumers may be ill-served by the federal regulators who are supposed to protect them from injury....more
The U.S. Food and Drug Administration (FDA) recently authorized the use of what it described as a “first-of-its-kind” medical device to treat infants for a birth defect called esophageal atresia, in which the upper esophagus...more
In a move sure to cause murmurs in the large and growing mobile health application industry, the Office of New York Attorney General Eric Schneiderman (OAG) has used state trade laws to extract concessions and monetary...more