FDA warns China’s Hong Qiangxing Shenzhen Electronics about Quality System violations in its production of several medical devices.
FDA warns Baton Rouge, LA-based Owen Biosciences about CGMP violations in its production of finished drugs as a contract manufacturing facility.
FDA warns China’s Hong Qiangxing Shenzhen Electronics about Quality System violations in its production of several medical devices.
FDA warns Baton Rouge, LA-based Owen Biosciences about CGMP violations in its production of finished drugs as a contract manufacturing facility.
FDA approves Novartis’ Itvisma (onasemnogene abeparvovec-brve), a new formulation of a gene therapy for a broader age of spinal muscular atrophy patients.
FDA issues a draft guidance with recommendations to help master file holders determine to which Center to submit cross-Center master files.
