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The FDA has released a final rule on radiological health that revises documentation requirements, allowing more time for submitting reports for accidental radiation occurrences (AROs).
The FDA has granted a priority review for Purdue’s abbreviated new drug application for nalmefene prefilled syringes for complete or partial reversal of opioid overdose.
The FDA has called for suggestions for how it should make use of user fee funding for two data reporting projects — premarket real-world evidence (RWE) activities and the Medical Product Safety Network (MedSun) program, a national surveillance network to collect postmarket data on medical devices.
In a postmarket study, Vasc-Alert’s surveillance technology successfully identified high-risk dialysis patients, a group seven times more likely to experience blood vessel narrowing, researchers reported in the Journal of Vascular Access.
Ceragroup Industries (CGI), a Florida manufacturer and distributer of dental porcelain products, recently received a Form 483 citing repeat problems with incomplete corrective and preventive action (CAPA) procedures and equipment lacking proper calibration.
“Real world” is a misleading and unnecessary term when it comes to data collection, says Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), who believes real-world evidence (RWE) should be treated the same as any other clinical evidence.