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PricewaterhouseCoopers says relations between industry and FDA over regulatory review processes are becoming strained.[ Price : $8.95]
FDA grants Cleveland BioLabs an orphan drug designation for CBLB502, a drug under development for treating radiation exposure.[ Price : $8.95]
CDER says that Ranbaxy is entitled to 180-day marketing exclusivity for generic Aricept.[ Price : $8.95]
PhRMA raises concerns with two aspects of an FDA draft guidance on developing drugs to treat acute bacterial skin and skin structu...[ Price : $8.95]
FDAs San Francisco District Office warns Align Technology of Medical Device Reporting violations associated with its Invisalign Sy...[ Price : $8.95]
FDA posts a 6/28 urgent Class 1 recall of B. Brauns fluid transfer addEASE binary connector because stopper fragments may enter a ...[ Price : $8.95]
Federal Register Notice: FDAs Neurological Devices Panel will meet 1/27-28/11 to discuss reclassifying electroconvulsive therapy d...[ Price : $8.95]
FDA releases an updated guidance document that provides recommendations on the chemistry, manufacturing, and controls information ...