The FDA has deemed Smiths Medical’s recall of its Medfusion model 4000 syringe pump as Class I for software issues that can make the pump fail and delay or interrupt…

With the composition, practice and utilization of data monitoring committees (DMC) changing considerably over the years, the FDA has published a new draft guidance on their use in clinical trials…

Despite FDA skepticism, the agency’s Circulatory System Devices Panel advisory committee endorsed Abbott’s TriClip, a transcatheter edge-to-edge repair system intended to treat tricuspid regurgitation. Source: Drug Industry Daily

FTC and HHS are jointly seeking more intel on how the practices of two types of pharmaceutical drug middlemen — group purchasing organizations (GPOs) and drug wholesalers — may be…

Two online marketers of semaglutide (Wegovy/Ozempic) and tirzepatide (Mounjaro) received FDA warning letters for selling the unapproved, untested drugs to consumers through their websites. Source: Drug Industry Daily

A federal judge in Texas has handed the Biden administration a win in its quest to control Medicare drug pricing, dismissing a lawsuit that challenged the legality of negotiating Medicare…

The FDA’s draft guidance on its Advanced Manufacturing Technologies (AMT) pathway would be restrictive to manufacturers in the cell and gene therapy spaces, the Alliance for Regenerative Medicine and the…

Following on the heels of a House subcommittee meeting to discuss FDA inspections of foreign drug manufacturers, the FDA released a scathing 483 inspection report of an active pharmaceutical ingredient…

Wayne Pines, Senior Director at APCO Worldwide, a former associate commissioner of the FDA, and a member of the FDAnews Editorial Board, reviews the FDA’s recent actions related to marketing…

A peer-reviewed analysis of data from a previous study of Masimo’s pulse oximetry device shows accurate measurement of oxygen saturation (SpO2) regardless of skin tones or pulse strength. Source: Drug…