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FDA warns Philadelphia, PA-based Medical Products Laboratories about CGMP violations in its manufacturing of unapproved new drugs.[ Price : $8.95]
FDA warns Livonia, MI-based Purolea Cosmetics Lab about CGMP and other violations in its production of finished drugs as a contrac...[ Price : $8.95]
Medical device regulation expert Adrienne Lentz describes the highlights from a 4/2 FDA Quality Management System Regulation town ...[ Price : $8.95]
FDA posts a draft guidance outlining how drug developers should evaluate the safety of human gene therapies that use genome editin...[ Price : $8.95]
Exelixis petitions FDA to require Handa Pharmaceuticals and others submitting a 505(b)(2) NDA for a caboztinib product referencing...[ Price : $8.95]
Three McDermott attorneys outline the key elements in an FDA 3/2026 guidance that helps establishments respond to an FDA-483.[ Price : $8.95]
FDA cites significant manufacturing and data integrity deficiencies at Hikal Limited following a 2/2025 inspection of the companys...[ Price : $8.95]
FDA approves Travere Therapeutics Filspari (sparsentan), a therapy for treating patients with Focal Segmental Glomerulosclerosis.