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The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with the sharing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
None of the nine pharmacy benefit managers (PBM) ordered in 2022 and 2023 to turn over business practice documents to the FTC have fully complied, FTC Chair Lina M. Khan told a bipartisan group of legislators who wrote in January seeking an update on the inquiry. Read More
Minerva Neurosciences has received a complete response letter (CRL) from the FDA on an NDA for the company’s schizophrenia drug roluperidone. Read More
The problem of potentially illicit, contaminated or low-potency counterfeit drugs coming into the U.S. from other countries is “huge,” but the government doesn’t have a handle on the true numbers, said FDA Commissioner Robert Califf on Wednesday during a Reuters Newsmakers webinar. Read More