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Researchers say manufacturers could make better use of predetermined change control plans for AI-enabled medical devices.[ Price : $8.95]
A Cooley legal analysis notes that FDA and federal prosecutors are signaling a tougher stance on failures to report patient safety...[ Price : $8.95]
FDA warns Alsip, IL-based GC America about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA extends its review of an AstraZeneca NDA for camizestrant, an experimental breast cancer therapy, after requesting additional ...[ Price : $8.95]
Corcept Therapeutics plans to resubmit its NDA for relacorilant as a treatment for patients with Cushings syndrome, following addi...[ Price : $8.95]
FDA approves an AbbVie NDA for Decnupaz (pivekimab sunirine-pvzy) and its use in treating adults with blastic plasmacytoid dendrit...[ Price : $8.95]
NSF consultants report on a webinar discussing the best practices in responding to inspection observations in a form FDA-483.[ Price : $8.95]
FDA warns Indias Alchymars ICM SM Private Limited about CGMP deviations in its production of active pharmaceutical ingredients.