Medtronic Neurosurgery recalls certain Becker and Exacta External Drainage and Monitoring Systems due to a risk for cracks and leaks in device stopcoc...
Federal Register notice: FDA delays by three months the effective dates of two final guidances on reducing the risk of transmission of sepsis-associat...
Olympus recalls its MAJ-891 endoscope accessory due to infection risks that may result from improper device reprocessing.
A Duane Morris client alert analyzes a recent FDA guidance on communicating scientific information to healthcare professionals about medical product u...
Pfizer seeks full approval for current accelerated-approved Braftovi (encorafenib) in combination with cetuximab (Erbitux) and mFOLFOX6 (fluorouracil,...
FDA clears an EssilorLuxottica 510(k) for its over-the-counter Nuance Audio Glasses that provide an open-ear hearing solution integrated into a pair o...
FDA approves a Vertex Pharmaceuticals NDA for Journavx (suzetrigine), a first-in-class non-opioid pain drug for treating moderate to severe acute pain...
Federal Register notice: FDA sends to OMB an information collection revision entitled Labeling Requirements for Prescription Drugs.
