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FDA releases a draft report entitled Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS) that describes ...[ Price : $8.95]
Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on exceptions or alternativ...[ Price : $8.95]
Federal Register Proposed order: FDA proposes to reclassify iontophoresis devices intended for any other purposes into Class 2.[ Price : $8.95]
CDER denies a 2006 citizen petition from physician John C. Kulli that requested it issue a regulation requiring attention deficit ...[ Price : $8.95]
FDA approves a de novo petition to allow the marketing of T2 Biosystems direct blood test for detecting five yeast pathogens that ...[ Price : $8.95]
FDA grants Regeneron Pharmaceuticals a breakthrough therapy designation for Eylea injection for treating diabetic retinopathy in p...[ Price : $8.95]
CDERs Office of Prescription Drug Promotion objects to a Cipher Pharmaceuticals e-Pharm/alert email for Lipofen (fenofibrate capsu...[ Price : $8.95]
A new House bill aims to close a loophole that is used by some brand drug makers to prevent potential generic drug firms from obta...