CDRH Office of In Vitro Diagnostics and Radiological Health director Timothy Stenzel discusses the growing importance of serology tests for Covid-19 d...
A Society of Corporate Compliance and Ethics white paper recommends ways to build a resilient healthcare supply chain once the coronavirus pandemic ha...
FDA warns Hungarys Mandelay Kft about Quality System violations in its manufacturing of two medical devices.
Boston Scientific recalls its Imager II 5F Angiographic Catheters because there is a potential for the catheter tip to become detached during a patien...
Two stakeholders comment on an FDA/FTC public workshop on a biosimilars competitive marketplace.
FDA clears a Nitiloop 510(k) for its NovaCross CTO Microcatheter and its use in intraluminal placement of conventional and steerable guidewires beyond...
FDA releases its latest batch of Warning Letters that includes Global Treat Srl, Mandelay Kft and Philip Kennedy.
Federal Register notice: FDA corrects a 1/8 Federal Register notice that announced the withdrawal 23 ANDAs.