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A law journal article, discussed in Regulatory Review, proposes a framework courts could use to consider state challenges to feder...[ Price : $8.95]
The Department of Justice says a Massachusetts federal judge sentenced three former Magellan Diagnostics executives for hiding a m...[ Price : $8.95]
FDA warns Chinas Hong Qiangxing Shenzhen Electronics about Quality System violations in its production of several medical devices....[ Price : $8.95]
FDA warns Baton Rouge, LA-based Owen Biosciences about CGMP violations in its production of finished drugs as a contract manufactu...[ Price : $8.95]
FDA approves Novartis Itvisma (onasemnogene abeparvovec-brve), a new formulation of a gene therapy for a broader age of spinal mus...[ Price : $8.95]
FDA issues a draft guidance with recommendations to help master file holders determine to which Center to submit cross-Center mast...[ Price : $8.95]
National Center for Health Research president Diana Zuckerman defends FDA advisory committees, saying they do a more thorough job ...[ Price : $8.95]
Novo Nordisk reports favorable Phase 2 data for its investigational dual-action obesity and diabetes drug amycretin, showing signi...