In a big win for the Food and Drug Administration (FDA), the D.C. Circuit of the United States Court of Appeals reinforced FDA’s position on what constitutes a “meaningful difference” between prescription and over-the-counter (OTC) versions of a drug product. Under FDA’s longstanding interpretation, section 503(b) of the Food, Drug, and Cosmetic Act (FDCA) “does
In a Federal Register notice published September 1, 2016, the U.S. Food and Drug Administration (FDA) announced a public hearing for November 9-10, 2016 on issues related to industry communications about unapproved uses of approved drugs, biological products and approved, cleared and exempt medical devices. FDA seeks input from a broad array of stakeholders, including
On December 3, 2012, the Court of Appeals for the Second Circuit issued an opinion in the matter of United States v. Caronia, which has received substantial attention in the national and pharmaceutical trade press. Hogan Lovells’ analysis of that opinion and its potential implications is available here.
The U.S. Department of Justice (DOJ) announced another significant settlement with a pharmaceutical company earlier this week. The settlement with GlaxoSmithKline PLC (GSK) includes: a criminal plea, through an Information charging the company with two counts of misdemeanor misbranding as well as a single count for failure to report information about the initiation or status