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Bipartisan members of the House introduce legislation to require FDA to produce a final rule to implement animal testing reforms a...[ Price : $8.95]
FDA grants Orthoson a breakthrough device designation for its Bio-Structural Gel and its use to reduce back pain caused by degener...[ Price : $8.95]
FDA accepts for priority review an Amgen supplemental BLA for Blincyto (blinatumomab) for treating early-stage, CD19-positive B-ce...[ Price : $8.95]
FDA publishes a draft guidance with information on how applicants and manufacturers should inform the agency about discontinuance ...[ Price : $8.95]
FDA warns Saint-Laurent, Canada-based Les Importations Herbasant about CGMP violations in its work as a contract drug manufacturer...[ Price : $8.95]
Three SheppardMullin attorneys say a recent Office of Prescription Drug Promotion untitled letter shows how FDA will continue to m...[ Price : $8.95]
FDA warns Chinas Nantong Furuida Packaging Products about a CGMP violation in its manufacturing of over-the-counter drugs.[ Price : $8.95]
FDA tells Vanda Pharmaceuticals that its ongoing review of a Hetlioz (tasimelteon) supplemental NDA has identified deficiencies th...