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Ahead of this week’s meeting in Kyoto, Japan, members of the International Medical Device Regulators Forum have offered a sneak peek into what they will discuss during the event. Read More
Looking to advance personalized medicine and customize patient care, the FDA is seeking stakeholder input on the challenges and opportunities of next-generation sequencing-based clinical tests to guide its regulatory approach toward these products. Read More
With an eye toward spurring innovation and advancing research, the FDA has added a vast amount of information to a website geared toward researchers and other parties looking to gain insight into the agency’s activities. Read More
Three men have agreed to settle U.S. Securities and Exchange Commission charges that they engaged in insider trading ahead of GE Healthcare’s 2010 purchase of Clarient, a cancer diagnostics company. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is advising companies that remanufacture single-use medical devices that they are subject to the same adverse event reporting requirements as original equipment manufacturers. Read More
Belgium-based Euromi has been hit with a far-ranging FDA warning letter that chides the company for not properly handling complaints, including cases of cannula tips from a liposuction system breaking and lodging in patients. Read More
Device makers are paying close attention to a federal court’s ruling that Amarin can use off-label promotion of its cholesterol-lowering drug Vascepa, as long as the communication is truthful and not misleading, two experts say. Read More
The FDA hit Baxter’s Synovis unit with a Form 483 for not initiating corrective and preventive actions for nonconformities to its Terminally Sterilized Vascu-Guard patch. Read More
For years, medical device companies have complained of their frustration with inconsistency in decisions by different FDA reviewers. A new program is aiming to change that — at least for startups. Read More