The Dayton Chamber of Commerce doesn’t represent any of the pharmaceutical giants affected by the drug negotiation provision of the Inflation Reduction Act (IRA), HHS says in its motion to…

The FDA has issued final guidance on charging for investigational new drugs in clinical trials, offering a minor update to its recommendations. In addition, the agency has published new draft…

This week, your watch can start alerting you to sleep apnea, a fingertip clip can monitor your daytime blood oxygen, and a robotic exoskeleton can help restore mobility to spinal…

The presentation and accuracy of medical information through traditional and social media — and even the headlines that accompany it — directly impact the nation’s health, FDA Commissioner Robert Califf…

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and utilization of data monitoring committees (DMC) changing considerably over the years, the FDA has published a new draft guidance on their use in clinical trials…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