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St. Jude Medical and Covidien recommend that FDA communicate future and study design considerations to IDE sponsors outside of the...[ Price : $8.95]
Johnson & Johnson drug unit Janssen Pharmaceuticals recalls one lot of antipsychotic drug Rispedal Consta (risperidone) long-actin...[ Price : $8.95]
Gilead Sciences files an NDA for idelalisib, an investigational targeted oral inhibitor of PI3K delta for treating indolent non-Ho...[ Price : $8.95]
FDAs Oncologic Drugs Advisory Committee recommends accelerated approval for Genentechs Perjeta for an indication for neoadjuvant t...[ Price : $8.95]
OvaScience says it is suspending U.S. enrollment of its Augment in vitro fertilization egg enhancement product while it discusses ...[ Price : $8.95]
Federal Register Advance notice of proposed rulemaking: FDA extends the comment period to 11/22 on a 7/24 request for comments on ...[ Price : $8.95]
CDER director Janet Woodcock says the GDUFA Human Capital Team has hired and trained 234 new employees for GDUFA implementation.[ Price : $8.95]
CDER deputy director for clinical science Bob Temple says drug reviewers are becoming more aggressive with drug sponsors and their...