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Dan O’Leary, president of Ombu Enterprises, explained the requirements for handling nonconforming products during an FDAnews webinar last month. The following is adapted from that event.Read More
President Barack Obama has established a new task force as part of an initiative that aims to support cancer research and enable progress for treatment of the disease. Read More
With the FDA continuing to see nontraditional methods of sterilization, the agency is advising sponsors on what to include in their 510(k)s for devices labeled as sterile. Read More
Sunlamp manufacturers would be required to take additional measures to improve the overall safety of tanning beds under new rules proposed by the FDA. Read More
A Senate report that followed an investigation by Sen. Patty Murray’s (D-Wash.) office has found that the FDA’s regulatory system for monitoring the safety of devices failed to quickly identify and resolve the spread of antibiotic-resistant infections linked to duodenoscopes. Read More