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FDA publishes an immediately-effective guidance to help drug manufacturers, repackers, and compounders prevent the use of glycol-c...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection revision entitled Expanded Access to Investigational Drugs for...[ Price : $8.95]
FDA warns Carlsbad, CA-based Premier Nutra Pharma about CGMP violations in its work as a contract drug manufacturer.[ Price : $8.95]
The DC federal court says FDA is correctly regulating Ipsen Biopharmaceuticals Somatuline Depot as a drug rather than as a biologi...[ Price : $8.95]
FDA clears a Cumulus Neuroscience 510(k) for its dry-sensor Cumulus EEG headset and its use for the remote acquisition, display, a...[ Price : $8.95]
FDA accepts for review a Genentech supplemental BLA for Vabysmo (faricimab-svoa) for treating macular edema following retinal vein...[ Price : $8.95]
FDA grants Acrivon Therapeutics two fast track designations for developing ACR-368 (prexasertib) in platinum-resistant ovarian can...[ Price : $8.95]
Two Hyman, Phelps & McNamara attorneys and a medical device regulation expert analyze a recent FDA draft guidance on artificial in...