[ Price : $8.95]
FDA cites a Pharmacia & Upjohn drug manufacturing facility in Kalamazoo, MI for GMP issues following a July inspection.[ Price : $8.95]
Attorney Jennifer Thomas says companies should ensure that promotional activities are given a thorough medical, legal, and regulat...[ Price : $8.95]
Attorney James Beck refuses cases that have held that making changes to a branded drugs formula is preempted under the Supreme Cou...[ Price : $8.95]
FDA posts a new electronic common technical document guide entitled eCTD Technical Conformance Guide, Version 1.0.[ Price : $8.95]
FDA says it will not revise and restrict a 2014 safety warning issued about the risk of rare but serious neurologic problems assoc...[ Price : $8.95]
FDA clears a Vertera Spine 510(k) for its Coher Cervical Interbody Fusion Device, which features the companys PEEK Scoria biomater...[ Price : $8.95]
FDA clears a Hitachi Medical Systems America 510(k) for its Supria 16-slice CT (computerized tomography) system.[ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Acceptability of Draft Labeling to Support ANDA Approval.