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CBER director Peter Marks says FDA is working to achieve 90% correct decisions on gene therapy accelerated approvals.[ Price : $8.95]
Three Winston & Strawn attorneys say that by declining to hear an appeal, the Supreme Court has affirmed that some state law claim...[ Price : $8.95]
FDA warns Chinas Bioptimal International about multiple violations at a Singapore facility manufacturing two unapproved catheters....[ Price : $8.95]
Federal Register notice: FDA announces that CDRH Office of Product Evaluation and Quality has modified its organizational structur...[ Price : $8.95]
FDA approves an AB therapeutic equivalence code for cancer drug paclitaxel suspension and tells HBT Labs it must formally apply fo...[ Price : $8.95]
FDA warns Dr. Kevin Bender, doing business as DBC Research in Tamarac, FL, about violations in his conduct of clinical trials.[ Price : $8.95]
Endo is ordered to pay $1.85 billion in fines and forfeitures after pleading guilty to introducing misbranded Opana ER into inters...[ Price : $8.95]
Six Hogan Lovells attorneys comprehensively analyze the new FDA final rule on laboratory-developed tests and predict industry stak...