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. Source: Drug Industry Daily
The FDA needs to regain the authority to regulate drugs used in executions, according to nine Democratic senators who Tuesday wrote separate letters to FDA Commissioner Robert Califf and Drug…
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…
The collaborative efforts that advance the development of more generic drugs is the work of CDER’s science and research program whose 2023 annual report provides details on the efforts behind…
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. Source: Drug Industry…
A federal appeals court has upheld a lower court ruling that the controversial 340B Drug Discount Program doesn’t stop drugmakers from restricting deliveries of discounted drugs to contract pharmacies. Source:…
Bristol Myers Squibb (BMS) and three US subsidiaries of Paris-based Sanofi owe the state of Hawaii a combined $916 million over safety disclosure failures with blood-thinning drug Plavix, following a…
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will attempt to balance the benefits of Novo Nordisk’s once-weekly insulin injection Awiqli with an increased risk of moderate and severe hypoglycemia…
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.…
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…