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CDRH posts a final guidance on Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container...[ Price : $8.95]
FDA sends Avanir Pharmaceuticals a complete response letter on its NDA for AVP-825, a drug-device combination of low-dose sumatrip...[ 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]
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 ...[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on humanitarian use devices to the Office of Management ...[ Price : $8.95]
Federal Register Notice: FDA amends a notice of an upcoming public workshop of the Sentinel Initiative.