In October 2023, the FDA released draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers...more
On December 29, 2022, President Biden signed into law H.R. 2617, the Consolidated Appropriations Act of 2023 (CAA23). Buried in this massive piece of legislation is Section 3621, Regulation of Certain Products as Drugs, which...more
How does the U.S. Department of Justice (DOJ) intend to leverage its enforcement authority under the False Claims Act to advance DOJ’s recently announced Civil Cyber-Fraud Initiative?
In this episode of Diagnosing Health...more
The COVID-19 pandemic spurred record growth in the dietary supplement industry in 2020. With this heightened consumer interest and many new entrants to the market, important questions have emerged about the adequacy of the...more
The Biden administration has invoked the Defense Production Act ("DPA") to speed up the production of vaccines and increase the domestic production of COVID-19 tests, personal protective equipment (or “PPE”), and other...more
Artificial Intelligence (“AI”) applications are powerful tools that already have been deployed by companies to improve business performance across the health care, manufacturing, retail, and banking industries, among many...more