U.S. federal government enforcement of the Foreign Corrupt Practices Act (FCPA) might not draw the attention that other matters draw, but the Securities and Exchange Commission (SEC) has made extensive use of the FCPA in 2020. SEC actions related to the FCPA may have accounted for only about 2% of the agency’s actions over the past year, but nonetheless accounted for nearly 80% of the penalties collected by the agency, and health care was second only to the oil and gas industries as the targets of FCPA action by the agency.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: U.S. FDA provides updates on power morcellation; FDA seeks nominations for advisory committee; CDSCO suspends import notification requirements.
Hopes continue to rise as the COVID-19 vaccine beat goes on and Operation Warp Speed (OWS) lives up to its name, with Moderna Inc. netting another U.S. Department of Defense contract worth about $1.97 billion for another 100 million doses – an order that brings to about $6 billion the company’s government contracts for the product, which was granted emergency use authorization (EUA) earlier this month.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Distalmotion, Inex Innovate, Quanterix.
The latest global regulatory news, changes and updates affecting biopharma, including: Arguments against transparency fall flat; CMS unveils push toward digital collection of quality measures.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alkermes, Ampio, Arcturus, Capricor, Celltrion, Clovis, Chi-Med, Moleculin, Novo Nordisk, Pfizer.
Rapid Medical Ltd.'s journey took a promising turn with a U.S. FDA clearance of Drivewire, the company's steerable guidewire for neuro and peripheral vasculature. Drivewire allows surgeons to adjust the shape of the tip while traversing challenging vasculature. It is the first neurovascular guidewire with a controllable distal end that permits on-demand course and shape changes during a procedure.
Heru Inc., a medical technology company using artificial intelligence (AI) to advance vision diagnostics and augmentation, has completed class I device registration with the U.S. FDA for its cloud-based diagnostic application for visual field exams. Heru’s software works with commercially available augmented reality or virtual reality (AR/VR) headsets to provide a subjective visual field exam, with results immediately available to clinicians through a web portal.
Although it held off on a proposed rule change addressing yet another gaming opportunity for drug manufacturers in the U.S., the Centers for Medicare & Medicaid Services (CMS) still is pressing its policy for including more 505(b)(2) drugs in multiple source reimbursement codes, which could force them to compete with generics on price.
The U.S. FDA has exercised a considerable degree of enforcement discretion during the COVID-19 pandemic, particularly when it comes to digital health. However, Christine Bump, principal at Penn Avenue Law & Policy, said that this very discretion has an uncertain shelf life and advised industry to remain compliant with the regulations as much as possible to avoid unnecessary enforcement actions by federal agencies.
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