The U.S. Department of Justice (DoJ) reported a new set of policies dealing with federal prosecutions of corporate misconduct that includes a far-reaching policy on disclosure. Deputy attorney general Lisa Monaco announced Oct. 28 that companies will have to disclose all non-privileged information in connection with alleged misconduct rather than just information regarding those who were “substantially involved.”
A former sales rep for Cambridge, Mass.-based Aegerion Pharmaceuticals Inc. was sentenced Oct. 28 to 54 months in prison and three years of supervised release for a scheme to defraud insurance companies and boost his bonuses for sales of Aegerion’s cholesterol drug, Juxtapid (lomitapide).
Biopharma scored a victory of sorts in the ongoing 340B war that’s pitting drug companies against the combined forces of hospital groups, contract pharmacies and the U.S. Department of Health and Human Services.
The FDA has granted emergency use authorization (EUA) to the COVID-19 vaccine created by Pfizer Inc.-Biontech SE for use in children ages 5 through 11. This is the first EUA for a COVID-19 vaccine to be awarded for this group of roughly 28 million children in the U.S. and it comes after weeks of lengthy debate among experts about the wisdom of targeting the young demographic.
The world of artificial intelligence (AI) regulation is still in its infancy, but a number of agencies are nonetheless keen on harmonization for at least some of this policymaking task. The FDA announced recently that it has joined with Health Canada and the U.K. Medicines and Healthcare Products Regulatory Agency to develop a series of 10 guiding principles for good machine learning practices (GMLP), thus answering one of the key questions facing developers of these algorithms.
The FDA has undertaken several new actions in connection with breast implants, including a new restriction on distribution to implant centers that review a pre-implant checklist with patients receiving implants. However, the agency has also mandated that manufacturers add a black-box warning of potential adverse events, such as the risk of developing anaplastic large cell lymphoma (ALCL).
PARIS – Mauna Kea Technologies SA reported the commercial launch of a new generation of its in vivo cellular imaging for diagnostics in gastroenterology. At the same time, the company is deploying its new needle-based and miniprobe-based multidisciplinary confocal laser endomicroscopy platform in the U.S., as well as in France, Germany and Italy.
In an effort to advance a fiscal 2022 spending package through a divided Congress, U.S. President Joe Biden released the framework for his Build Back Better agenda Oct. 28 – minus provisions that would allow Medicare to directly negotiate at least some prescription drug prices.
The U.S. Department of Health and Human Services is proposing to withdraw or repeal a Trump-era rule imposing expiration dates on most of the rules implemented by the department and its agencies, including the FDA.
The FDA has struggled to revise a guidance related to cybersecurity in medical devices, but developers now have more than just lagging FDA guidances to worry about where cybersecurity is concerned. The U.S. Department of Justice (DoJ) has unveiled a program designed to leverage the False Claims Act to pursue entities that come up short of regulatory expectations for cybersecurity, constituting a new vector for liability for makers of devices and medical software.
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