Attorneys for a device company CEO facing criminal charges for off-label promotional speech are asking for the case be thrown out on grounds of prosecutorial misconduct.
Federal prosecutors manipulated witnesses and misinterpreted the law in bringing criminal charges against the CEO of Vascular Solutions Inc., attorneys for the device-maker say.
The case is drawing a growing amount of attention in the device community because many executives fear the indictment of Vascular Solutions CEO Howard Root for conspiracy and illegal promotion...
The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.
A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
