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Industry advocates challenge conclusions in a JAMA Internal Medicine analysis of the cost and potential revenue involved in develo...[ Price : $8.95]
Drug companies say FDA should do more work on its draft document on standardization of pharmaceutical quality and chemistry, manuf...[ Price : $8.95]
FDAs Medical Imaging Drugs Advisory Committee votes to recommend a warning about gadolinium retention for gadolinium-based contras...[ Price : $8.95]
CDER director Janet Woodcock tells a House Energy and Commerce Health Subcommittee hearing that the current monograph system for o...[ Price : $8.95]
A Tufts Center for the Study of Drug Development analysis finds that the FDA approval rate for cardiovascular drugs has dropped 52...[ Price : $8.95]
FDA warns HomeoCare Laboratories about CGMP violations in its production of three misbranded homeopathic drugs.[ Price : $8.95]
FDA warns Dynavision that its D2 device is adulterated and misbranded and fails to conform to Quality System regulation requiremen...[ Price : $8.95]
FDA issues a draft guidance on recommended nonclinical studies for microdose radiopharmaceutical diagnostic drugs.