The HHS Office of Inspector General issues a favorable advisory opinion regarding a sponsor’s payment of cost-sharing amounts in a Medicare Category B IDE Clinical Study; the FDA issues guidance regarding the use of Digital...more
FDA releases updated guidance regarding the Q-Submission Program; C.R. Bard faces an unusual result in its patent dispute with AngioDynamics; A nurse practitioner pleads guilty to committing health care fraud by using...more
On May 2, 2023, the U.S. Department of Justice (DOJ) announced the indictment of two New York state pharmacy owners, Taesung Kim and Dacheng Lu, for their participation in an alleged $29 million healthcare fraud scheme. Kim...more
On July 20th, on the eve of trial, Biogen Inc. agreed to pay $900 million dollars to settle claims that the company violated the False Claims Act (FCA) by allegedly paying improper consulting and speaker fees and providing...more