FDA classifies as Class 1 a GE Healthcare recall of its CareScape R860 Inspiratory Safety Guard, a breathing accessory designed for use with the Cares...
FDA clears a DBM Corp. 510(k) for its Miracu PDO Suture Threads and its use on soft tissue approximation where absorbable sutures are appropriate.
FDA warns Chinas Zhejiang Huahai Pharmaceutical Co. about significant CGMP deviations in its production of active pharmaceutical ingredients.
Olympus Medical Systems and a former senior executive plead guilty to failing to file required adverse event reports involving its duodenoscopes and a...
FDA warns Indias Skylark CMC over its refusal to permit agency inspectors to enter manufacturing areas and refusal to provide requested records.
Federal Register notice: FDA announces a 5/21 public meeting entitled FDAs Proposed Current Good Manufacturing Practice Policies for Outsourcing Facil...
Federal Register notice: FDA makes available a revised draft guidance entitled Current Good Manufacturing Practice Guidance for Human Drug Compoundin...
FDA commissioner Scott Gottlieb outlines provisions in four guidances to help advance the agencys Biosimilars Action Plan.