[ Price : $8.95]
FDA denies a Teva citizen petition that asked the agency to not approve any ANDA for its multiple sclerosis drug Copaxone (glatira...[ Price : $8.95]
FDA posts a guidance on Scale-up Post-approval Changes: Manufacturing Equipment Addendum to help manufacturers determine the docum...[ Price : $8.95]
The agency posts a final guidance on Infusion Pumps Total Product Life Cycle to assist industry in preparing premarket submissions...[ Price : $8.95]
An Internet security firm says it is currently tracking a group that targets the email accounts of senior employees at healthcare ...[ Price : $8.95]
FDA denies an Amarin Pharmaceuticals Ireland petition asking it to impose specific bioequivalence testing requirements on any ANDA...[ Price : $8.95]
Synthes begins a Class 1 recall of its Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws, reporting that two nonc...[ Price : $8.95]
FDA accepts for review an Ipsen BLA for Dysport (abobotulinumtoxinA) for use in treating upper limb spasticity in adult patients.[ Price : $8.95]
Federal Register Notice: FDA sends a proposed collection of information on the accredited person inspection program to the Office ...