[ Price : $8.95]
FDA accepts for review a Johnson & Johnson NDA for TAR-200 (gemcitabine), an intravesical drug releasing system for treating certa...[ Price : $8.95]
FDA warns Integra Lifesciences about Quality System Regulation violations in the manufacturing of neurological and neurosurgical m...[ Price : $8.95]
FDA warns Marlborough, MA-based Hologic about Quality System and Medical Device Reporting violations in its production of implanta...[ Price : $8.95]
Federal Register notice: FDA issues Novo Nordisk a priority review voucher for gaining approval for its hemophilia drug Alhemo (co...[ Price : $8.95]
Federal Register notice: FDA withdraws the approval of 12 NDAs from multiple applicants because they are no longer marketed.[ Price : $8.95]
The HHS Inspector General raises concerns about three of 24 drugs approved through the FDA accelerated approval pathway.[ Price : $8.95]
FDA says a new method of determining an acceptable intake limit for nitrosamine impurities in drugs that it helped to develop has ...[ Price : $8.95]
The Association for Accessible Medicines calls on FDA to produce several guidances for generic oligonucleotide drugs.