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Editor Jim Dickinson critiques a Wall Street Journal critique of outsourced FDA management training contracts and suggests the con...[ Price : $8.95]
Centocor submits a second 2010 sBLA to FDA seeking to broaden the indication for its Simponi.[ Price : $8.95]
Johnson & Johnson says it is trying to resolve potential federal civil and criminal charges relating to Risperdal marketing.[ Price : $8.95]
CDER director Janet Woodcock makes the case for a new federal research infrastructure to involve community doctors in comparative ...[ Price : $8.95]
NephRx begins a Phase 1 clinical trial of its lead compound NX001, a kidney growth factor peptide under development for preventing...[ Price : $8.95]
FDA denies a petition asking for changes in labeling for levothyroxine products.[ Price : $8.95]
UCB asks FDA to reject ANDAs from any generic drug manufacturer citing Xyzal as the reference-listed drug but carving out labeling...[ Price : $8.95]
FDAs Office of the Commissioner says it will hear Ethicons appeal of the CDRH decision that the companys Sedasys PMA is not approv...