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The 11th Circuit appeals court returns to a lower court a Bausch & Lomb whistleblower case to determine if a causal connection exi...[ Price : $8.95]
Members of FDAs Antiviral Drugs Advisory Committee unanimously recommend approval of Janssens simeprevir in treating some cases of...[ Price : $8.95]
NPS Pharmaceuticals submits a BLA for Natpara (recombinant human parathyroid hormone 1-84, rhPTH).[ Price : $8.95]
The Generic Pharmaceutical Association asks FDA many questions about its draft guidance on stability testing for ANDAs.[ Price : $8.95]
CDER launches a Web navigational tool for academic investigators working on IND applications.[ Price : $8.95]
FDA releases for comment the Therapeutic Area Standards project plan for PDUFA 5 drug and biologic clinical terminology standards....[ Price : $8.95]
Public Citizen wants a ban on FDA advisory committee members making presentations to industry on how best to get a favorable decis...[ Price : $8.95]
U.S. Oncology Research and BioMarin Pharmaceutical collaborate to launch a Phase 3 study of BMN 673, a poly ADP-ribose polymerases...