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While Shield, Guardant’s blood-based colorectal cancer screening test, got an overall thumbs-up from an FDA advisory committee, members stressed that it’s no substitute for colonoscopy. Read More
Hologic BioZorb Markers with excessive adverse event reports and Vyaire Medical’s Twin Tube with the potential for the nozzle separating during patient use have been deemed as Class I recalls by the FDA. Read More
This week, the FDA issued a final rule reclassifying ultrasound cyclodestructive devices and published a notice seeking nominations for advisory panels of the Medical Devices Advisory Committee. Read More
Drug shortages, patent tussles, and gripes about the Inflation Reduction Act (IRA) headlined the conversation at an FDA “check-up” meeting conducted by the House Energy and Commerce’s subcommittee on health. Read More
One of the biggest mistakes companies make in their responses to the FDA’s inspection observations is to focus on the specific issues raised without looking at the bigger picture, according to one regulatory compliance expert. Read More
NIH is seeking comments on a new policy that would require partnering organizations who receive institute funding to submit a plan outlining steps they will take — through a patent licensing agreement — to promote patient access to any resulting drug, biologic, vaccine or device. Read More
Magellan Diagnostics has agreed to plead guilty and pay $42 million for concealing a device malfunction for years that produced inaccurately low lead test results for potentially tens of thousands of children and other patients, including pregnant women. Read More
Congress needs to put more pressure on agencies like the FDA and the US Patent and Trademark Office (USPTO) to collaborate on fighting patent thickets, the multiple patents pharmaceutical companies file after a drug is already on the market to extend the drug’s period of exclusivity and keep generic alternatives off the market. Read More
The FDA has a lot of work to do to regain trust among a wide swath of demographic groups — starting with women — according to a recent survey. Read More