A former Olympus exec who took personal responsibility for the company’s failure to submit duodenoscope-related adverse event reports has been sentenced to one year’s probation and a $5,000 fine.
A former Olympus Corp. executive won’t serve any prison time for his role in failing to report adverse events tied to contaminated duodenoscopes.
Hisao Yabe was Olympus’s top US regulatory executive in 2012 and 2013, when the company’s duodenoscopes were tied to three separate infectious disease outbreaks in French and Dutch hospitals that...
The consumer genomics firm will operate as a subsidiary, while Regeneron plans to leverage its database for drug discovery and trial design efforts.
FemTech leaders discussed some of the barriers that remain in unlocking the full potential of the women’s health market during SiS New York last week. They also offered solutions.
A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.
