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Federal Register Direct final rule: FDA requires that NDA sponsors submit certain information on authorized generic drugs in an an...[ Price : $8.95]
CDER director Janet Woodcock says a decision tree on data to include and omit from cancer drug submissions is near and commissione...[ Price : $8.95]
FDA commissioner Andrew von Eschenbach reassures reporters that FDAs concern over product safety is Job 1, before promotion of pub...[ Price : $8.95]
EthicAd, a private sector collaborator in a new FDA Web site on DTC ads, says its members work with the drug industry but voluntee...[ Price : $8.95]
FDA approves Eli Lillys Alimta for use in combination with cisplatin for first-line treatment of locally-advanced and metastatic n...[ Price : $8.95]
Sen. Herb Kohl wants to work with Rep. Bart Stupak to ensure that regulation of ads for both drugs and medical devices is consiste...[ Price : $8.95]
Attorney Kurt Karst says that Senate Bill 3560 would provide Waxman-Hatch benefits to antibiotics submitted to FDA before 11/21/97...[ Price : $8.95]
FDA fails to meet its extended PDUFA deadline for action on Daiichi Sankyo/Lillys prasugrel NDA.