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U.S. attorney Michael Sullivan says a medical device company manager pleaded guilty to making a false statement and misbranding.[ Price : $8.95]
Federal Register Notice: FDA releases a guidance, Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials.[ Price : $8.95]
FDA tells the Anti-infective Advisory Committee it sees mild to moderate adverse events in Novartis malaria drug Coartem.[ Price : $8.95]
Microtest Laboratories president Steven Richter says manufacturers of combination products will be challenged to keep up with incr...[ Price : $8.95]
Cephalon, Eurand, and Anesta AG file suit against Mylan Pharmaceuticals over its ANDA for a generic copy of muscle relaxant Amrix.[ Price : $8.95]
CDER issues a draft guidance on submitting patent information for certain old antibiotics.[ Price : $8.95]
FDA grants a priority review for a Cell Therapeutics supplemental BLA for Zevalin, indicated as first line consolidation therapy f...[ Price : $8.95]
Eli Lilly withdraws a supplemental NDA for Cymbalta (duloxetine HCl) seeking a new indication for managing chronic pain.