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The DOJ said the criminal resolution includes the second-largest set of criminal financial penalties ever levied against a pharmaceutical company. Read More
In a likely boost to Joe Biden’s affection for Delaware, a federal judge in U.S. District Court there Friday handed a victory to the President’s much-challenged Inflation Reduction Act (IRA), in another setback for big pharma in challenging the Medicare Part D drug pricing program. Read More
During the second session of the 118th Congress, FDAnews will track pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
The FDA’s Medical Imaging Drug Advisory Committee (MIDAC) meets Tuesday to tackle concerns about Lumisight, a device-injection combo product from Lumicell designed to help clinicians detect residual breast cancer following tumor removal. Read More
The letter to Delsam says that it contracts with Global Pharma Healthcare Private Limited, a UK-based contract manufacturer, for its products. Read More
The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with the sharing of essential clinical trial information in ways that patients can understand. Read More
When it comes to integrating artificial intelligence into healthcare networks, stakeholder enthusiasm appears to be outstripping FDA oversight, according to a survey by the Berkeley Research Group. Read More
Bankrupt Endo Health Solutions (EHSI) has agreed to plead guilty and pay just over $2 billion to resolve criminal and civil investigations, as well as its bankruptcy debt, related to the company’s sales and marketing of the opioid drug Opana ER (oxymorphone), the Department of Justice (DOJ) announced. Read More
The U.S. government should have to prove that the claims in False Claims Act (FCA) kickback cases would not have been submitted “but for” kickbacks, says Teva Pharmaceuticals in response its latest to a years-long back-and-forth with the Department of Justice (DOJ). Read More
The FDA has issued warning letters to three eye drop manufacturers as part of ongoing investigations into a multi-state outbreak of more than 80 antibiotic-resistant eye infections that have led to four patient deaths and at least 14 cases of vision loss. Read More