FDA grants BeiGene a fast track designation for BGB-16673 and its use in adult patients with relapsed or refractory chronic lymphocytic leukemia or sm...
FDA clears an Insulet 510(k) for the Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for use by those with Type 2 diabetes (ages 18 years and ...
Public Citizens Health Research Group calls on HHS Office of Inspector General to investigate allegations that retiring CDRH director Jeff Shuren fail...
CDER director Patrizia Cavazzoni says agency inspectors and reviewers are seeing deteriorating manufacturing quality in the facilities where biologics...
Federal Register notice: FDA makes available a final guidance entitled Electronic Submission Template for Medical Device De Novo Requests.
Federal Register notice: FDA is making available additional draft and revised draft product-specific guidances that provide recommendations on, among ...
FDA clears a SurGenTec 510(k) for its proprietary B-MAN Bone Marrow Aspirate Kit.
Inari Medical begins a Class 1 recall to update the use instructions for its ClotTriever XL catheter after discovering serious adverse events caused w...
