Top administration officials have become increasingly convinced Makary has to go because, in addition to months of turmoil, complaints from some in the pharmaceutical industry have continued to mount, people familiar with the matter said.
New pathway cuts red tape and brings predictability to Medicare coverage for Breakthrough Devices.
Patient Preference Information (PPI) guidance on when and what methods to use to collect and submit patient preference information (PPI) for a device to FDA.
The medical device industry and EPA have been in ongoing debate over balancing the need for sterile medical equipment with concerns about pollution near sterilization plants.
Global look at regulatory compliance, guidance, trends and deadlines.
A new EU Commission study on the Deployment of AI in Healthcare makes one thing crystal clear: AI isn’t just a buzzword, it could be the lifeline our systems desperately need.
Two locations selected to demonstrate Caspian, an automated, point-of-care, sterile saline manufacturing system that may help prevent or mitigate intravenous (IV) fluid shortages in the United States.
FDA issued General Correspondence Letters to two third-party testing companies in China after discovering data that was falsified or otherwise found to be invalid.
The FDA plans to expand generative AI capabilities—across all centers using a secure, unified platform.
The FDA conducts approximately 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries. U.S. manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process.