Harmonization and simplification won the day as the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) looked toward the future of COVID-19 vaccines in the U.S. Jan. 26. The committee voted unanimously, 21-0, to recommend using the same strain composition for all COVID-19 vaccines available in the U.S., whether they’re used for primary doses or boosters. Such standardization also would align the composition of Novavax Inc.’s protein-based vaccine with that of the mRNA vaccines produced by Moderna Inc. and Pfizer Inc.-Biontech SE.
Citing efforts to “encourage innovation,” China’s National Healthcare Security Administration included 111 new drugs in its National Reimbursement Drug List (NRDL). The adjustment, shared Jan. 18, 2023, also removed three drugs, leaving the latest NRDL with a total of 2,967 drugs. Most of the newly added drugs are recently approved drugs, with many making it to the market in the last five years. Twenty-three were approved in 2022.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alk-Abello, Cidara, Fabre-Kramer, Immuron, Inhibikase, Oncotelic, Poxel, Tango.
Fraud perpetrated on U.S. federal health care programs is the stuff of nightmares among U.S. enforcement agencies, and yet another pair of fraudsters have been rounded up by the Department of Justice (DOJ).
Brazilian health care regulator Anvisa unveiled new medical device rules that promise to simplify over two decades of accumulated directives, putting into force changes announced by the health care surveillance agency in 2022.
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.
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