More than one U.S. federal government agency is tasked with keeping track of fraud and abuse of federal health programs, but a new report by the Government Accountability Office (GAO) suggests there is more work to be done. The GAO report said that one of the key issues with fraud and abuse writ broadly is that the terms and definitions are used inconsistently, and that a fix for this and other problems might capture more fraud, which may in turn indirectly put more medical device makers at risk for such allegations.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Geneseeq Technology, Tidepool.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Axcella, Biontech, Carina, Cullinan, Decibel, Diamond, Immpact, Kura, Oxular, Pfizer, Polypid, Verrica.

Depuy Synthes Inc., of Raynham, Mass., has agreed to pay $9.75 million to settle allegations that several members of its sales team had induced an orthopedic surgeon to use the company’s products in orthopedic procedures by offering free implants and surgical instruments. The fine comes under the guise of a False Claims Act violation but might have been substantially larger but for the fact that Depuy reported the issue to federal authorities.

For the second time in recent weeks, Apple Inc. has come out on the losing side of a patent dispute adjudicated by the U.S. International Trade Commission (ITC), this time at the hands of Masimo Corp. While an ITC administrative law judge (ALJ) found for Masimo in connection with one of the company’s patents, Cupertino, Calif.-based Apple was cleared of any infringement in connection with four other Masimo patents, and the ITC has yet to officially declare what sort of remedy it will impose on Apple over the dispute with Irvine, Calif.-based Masimo.

Long before the U.S. Congress approved a path for importing prescription drugs from Canada to take advantage of their cheaper price, Poornanand Palaparty, an oncologist in Ohio, purchased cancer drugs from a Canadian distributor from 2004 to 2009. Now, nearly a decade after Palaparty pleaded guilty in 2013 to introducing misbranded drugs into the U.S., the FDA is debarring the doctor based on that federal misdemeanor.

Albeit with complaints and provisos, the U.S. FDA’s Antimicrobial Drugs Advisory Committee (ADAC) rubber-stamped Cidara Therapeutics Inc.’s rezafungin, an injectable treatment for candidemia and invasive candidiasis (IC) in adults. Panelists were asked to vote on a single question: “Is the overall benefit-risk assessment favorable for the use of rezafungin for treatment of candidemia/IC in adults with limited or no alternative treatment options?” The balloting turned out 14 yes, one no.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Icotec.