The issue of life science espionage continues to reverberate across the U.S., and a new report by the Office of Inspector General (OIG) suggests that vulnerabilities in the U.S. have not been adequately addressed. The OIG report said that more than two thirds of NIH grantees failed to meet at least one requirement for investigator disclosures about their activities related to foreign entities, including governments, a problem OIG says is in dire need of a fix.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Oncologica, Medicalgorithmics, Scopio, Thermo Fisher.
The U.S. CMS has suspended the rulemaking for payment for radiation oncology for Medicare patients, but the suspension hasn’t assuaged the fears of industry and health care professionals. Anne Hubbard, health policy director for the American Society for Radiation Oncology told BioWorld that despite the suspension, CMS’s interest in the much-criticized proposal for site-neutral payment is unlikely to ebb anytime soon.
News that the U.S. FTC is finally going to reexamine the role of pharmaceutical benefit managers (PBMs) and their impact on prescription drug prices and availability is playing to applause from several sectors that have been complaining for years about PBM practices.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lumiradx, Proscia.
The U.S. FDA’s device center continues to promote alternatives to ethylene oxide (EtO) as a medical device sterilant, with the latest development involving radiation as a sterilizing technology. The agency said it may open a new master file program for radiation that follows an existing program that is agnostic as to sterilization method, and which may speed the adoption of alternative sterilization methods in the years ahead. The FDA’s Center for Devices and Radiological Health recently announced a pilot program for alternatives to EtO sterilization that would eliminate a significant number of regulatory filings.
Abbott Laboratories received FDA clearance for its Freestyle Libre 3 continuous glucose monitoring system (CGM) just before the kickoff of the American Diabetes Association (ADA) annual meeting June 3 followed by breakthrough device designation for a combined CGM and continuous ketone monitoring system.
Global regulatory activity has fallen slightly, partially due to a decline in pandemic activity, and U.S. FDA approvals of drugs and biologics are at their lowest levels in five years.
The U.S. FDA’s accelerated approval path is front burner these days, what with Congress looking to modernize the path through provisions added to the must-pass user fee legislation, the controversy still boiling over the FDA’s accelerated approval last year of Biogen Inc.’s Alzheimer’s drug, Aduhelm (aducanumab), and a number of recent withdrawals of drugs granted accelerated approval years ago.
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