SterRx recalls three lots of sodium bicarbonate in 5% dextrose injection 150mEq per 1,000 mL due to waterborne microbial contamination.
CNN reports it has been told by two administration officials that it could be weeks until a permanent FDA commissioner is named.
FDA clears an Able Medical Devices 510(k) for its Mach Screw Clip System, a single-use, sterile screw delivery device.
FDA clears a 3NT Medical 510(k) for its single-use Peregrine Drivable Ear Nose and Throat Scope.
FDA grants Lantern Pharma an orphan drug designation for LP-184 and its use in treating pancreatic cancer.
Federal Register notice: FDA announces a 9/17 Pediatric Advisory Committee to discuss a pediatric-focused safety review of Cook Medicals Flourish, an ...
Federal Register notice: FDA establishes a public docket to collect comments related to the post-marketing pediatric-focused safety reviews of product...
KVK Tech recalls two lots of atovaquone oral suspension, USP 750 mg/5mL based on customer complaints of unusual grittiness in the product.