[ Price : $8.95]
The 5th Circuit Court of Appeals upholds a Texas federal court ruling granting summary judgment to Solvay Pharmaceuticals in a whi...[ Price : $8.95]
FDA releases a draft guidance on statistical approaches to evaluating analytical similarity between biosimilars and their referenc...[ Price : $8.95]
An FDA safety alert warns that Intercept Pharmaceuticals liver disease drug Ocaliva (obeticholic acid) is being incorrectly dosed ...[ Price : $8.95]
FDA clears a Brainlab 510(k) for Elements Spine SRS and Elements Cranial SRS, two software applications that aid in the patient-ta...[ Price : $8.95]
Public Citizen asks the DC federal court to compel FDA to act on the advocacy groups petition asking that benzocaine not be permit...[ Price : $8.95]
Attorney Mark DuVal faults what he sees as FDAs new, less collaborative approach to determining whether a 510(k) is substantially ...[ Price : $8.95]
FDA clears a ClaroNav 510(K) for NaviENT, a computer-assisted surgical navigation system for surgical procedures inside a patients...[ Price : $8.95]
Federal Register notice: FDA announces a 10/24-25 public meeting entitled 2017 Scientific Meeting of the National Antimicrobial Re...