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FDA publishes an ICH guidance on evaluating the viral safety of biotechnology products derived from human or animal cell lines.[ Price : $8.95]
FDA says it has not been able to establish a causal connection between suicidal ideation and drugs like Ozempic and Wegovy and is ...[ Price : $8.95]
Four major stakeholder groups air their disagreement with an FDA revised draft guidance on firms communicating scientific informat...[ Price : $8.95]
FDA clears a Zeta Surgical 510(k) for its Zeta Cranial Navigation System.[ Price : $8.95]
Busse Hospital Disposables recalls its Tracheostomy Care Tray, Dressing Change Tray, and Tracheostomy Care Set in response to Nurs...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Requests for Reconsideration at the Division Level Under GD...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection revision entitled Electronic Records; Electronic Signatures 2...[ Price : $8.95]
FDA warns South Koreas Woorilife & Health about CGMP violations in its manufacturing of over-the-counter drugs.