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FDA clears an Ikonisys 510(k) for the oncoFish HER2 test, intended for use in determining a patients HER2 status in human breast c...[ Price : $8.95]
CDERs Office of Generic Drugs publishes a clarifying question-and-answer document on residual solvents in ANDAs.[ Price : $8.95]
FDAs New Jersey District Office warns LifeCell over Quality System violations at its manufacturing facility.[ Price : $8.95]
Federal Register Final rule: FDA confirms an interim final rule requiring certain approved human drug products to bear a toll-free...[ Price : $8.95]
Shire asks FDA to issue a guidance requiring in vivo studies with clinical endpoints and rigorous dissolution testing to support a...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Bayer Healthcare, BioMedical Vascular Solutions, C Change Surgical, LifeCell, an...[ Price : $8.95]
Digestive Care submits an NDA for Pancrecarb, indicated for use in treating exocrine pancreatic insufficiency.[ Price : $8.95]
Panelists at an Institute of Medicine forum express confusion about the further development sources of biomarkers while recognizin...