After almost a decade devoted to implementing unique device identifier (UDI) regulations, the FDA is now focused on enforcing them, says UDI expert Jay Crowley, a former FDA official who…

A company-initiated recall of nearly 68,000 Olympus bronchoscopes is now deemed class I by the FDA because of the risk of endobronchial combustion, which could cause serious injuries or death.…

FDA Commissioner Robert Califf said he believes the FDA can take steps to improve the current system for postmarket evaluation of drugs and make major renovations that address its current…

Upcoming events in the coming weeks and months include three FDA advisory committee meetings; MAGI 2024: The Clinical Research Conference; and webinars on medical device cybersecurity, overcoming common clinical trial…

The manufacturer of eye drops linked to more than 80 adverse reactions, including 14 cases of blindness and four deaths, received a 15-page FDA warning letter calling the company out…

IQVIA, the global contract research organization juggernaut, has filed its opposition to the FTC’s proposed preliminary injunction halting its acquisition of Propel Media, the latest in its back and forth…

Cisplatin, a commonly used chemotherapy drug prescribed to treat several advanced forms of cancer, is again under production by Accord Healthcare, the FDA said Monday. Source: Drug Industry Daily

Bayer is issuing a voluntary withdrawal of Aliqopa (copanlisib) after the PI3K inhibitor failed to meet the primary endpoint of progression-free survival in its postmarketing confirmatory trial. Source: Drug Industry…

Our health care delivery system is changing every day. New medicines, innovative research, new reimbursement policies, doctors burning out and retiring, telemedicine, emergency room delays — these and other changes…

Stolen defective laryngoscopes offered for sale on Facebook Marketplace are now part of a manufacturer recall the FDA has deemed as class I, the most serious type of recall as…