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The FDA has extended its delay on conducting in-person domestic surveillance in-spections through Feb. 4 with the goal of restarting the activities as soon as safely pos-sible. Read More
In responses to two Republican senators, Robert Califf — the Biden administration’s nominee for FDA commissioner — provided a deeper look into the priorities he would set at the helm of the agency if confirmed to the top post once again. Read More
New Britain, Pa.-based Thrombolex said its endovascular-thrombolytic delivery system cleared 90 percent of totally occluded pulmonary arteries in an interim analysis from a pivotal trial. Read More
In its continuing effort to hire highly skilled senior executives from the private sector, the FDA took advantage of provisions in the 21st Century Cures Act to offer higher salaries than it could under traditional federal hiring authorities, but it still needs an overall workforce strategy for drugs and devices, the Government Accountability Office (GAO) said in a new report. Read More
Apple’s electrocardiograph (ECG) software for over-the-counter use, available as an app, has received a risk downgrade from the FDA to class II (special controls) as opposed to the highest-risk class III category. Read More
The FDA has failed to send Congress a required commitment letter for reauthorization of the Medical Device User Fee Act (MDUFA) by the Jan. 15 deadline. Read More