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The FDA issued final guidance on user fees and refunds for device biologics license and premarket approval applications with just minor changes from the October 2017 draft. Read More
FDA Commissioner Scott Gottlieb noted an increase in new drugs targeting specific molecular markers that drive the growth and spread of cancer. Read More
Ev3 agreed to plead guilty to misdemeanor charges that it encouraged unproven and potentially dangerous uses of its Onyx Liquid Embolic System. Read More
The FDA issued separate draft guidances on blood glucose monitors used in health care settings and on over-the-counter products used in the home. When finalized, they will replace guidances the agency issued in 2016. Read More
The FDA has withdrawn a proposed rule that would have required manufacturers to submit labels and package inserts in electronic format for certain home-use medical devices. Read More
The FDA plans to continue building out its National Evaluation System for health Technology (NEST) and it is increasing its focus on device therapies unique to women, Commissioner Scott Gottlieb and CDRH Director Jeff Shuren said in a joint announcement. Read More
The FDA is seeking public comment on how it should regulate prescription drug software apps and says some software applications might have to be regulated as a device — such as a software program that uses advanced algorithms to scan skin lesions for evidence of cancer. Read More