FDA clears a Meditech Spine 510(k) for its Cure Opel-C Plate System, an add-on technology to its already cleared Cure ACP System and Talos-C (HA) Inte...
Federal Register notice: FDA establishes a public docket to collect comments related to the post-marketing, pediatric-focused safety reviews of produc...
Federal Register notice: FDA announces a 10/24-25 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss the agencys Guidance for In...
Attorney Bradley Thompson says an FDA announcement of the faster-than-usual clearance of two Apple products the day before a product promotion meeting...
International Contrast Ultrasound Society petitions FDA urging it to remove boxed warnings from ultrasound contrast agents based on current highly fav...
FDA warns Pharmaceutical Laboratories and Consultants about repeat CGMP violations and other issues in its work as a contract laboratory testing OTC d...
FDA denies a 2009 petition asking it to recall vaccines containing unsafe ingredients.
FDA releases its latest batch of Warning Letters that include ITG-Medev, Jabones Y Productos and Pharmaceutical Laboratories and Consultants.