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FDA publishes a draft guidance with information on how applicants and manufacturers should inform the agency about discontinuance of or interruptions ...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