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Federal Register Notice: FDAs Circulatory System Devices Panel will meet 10/13 to discuss a Cook, Inc. PMA for the Zilver-PTX drug...[ Price : $8.95]
Federal Register Notice: FDA seeks industry organizations interested in participating in selecting non-voting industry representat...[ Price : $8.95]
CDER director Janet Woodcock tells the OTC drug industry that outdated drug monographs on which many of them rely are a risk to th...[ Price : $8.95]
Federal Register Notice: The Office of Management and Budget approves a collection of information on exemption from substantial eq...[ Price : $8.95]
Federal Register Notice: FDA plans a public meeting on the reauthorization of the Prescription Drug User Fee Act for fiscal years ...[ Price : $8.95]
FDA issues Janssen Biotech a complete response letter on a supplemental BLA for Simponi (golimumab) seeking an expanded label for ...[ Price : $8.95]
The European Fine Chemicals Group says it is backing FDAs legislative proposal for a generic drug user fee program.[ Price : $8.95]
FDA clears a Fluke Biomedical 510(k) for the ProSim Vital Signs Simulator.