Medical device regulation expert Adrienne Lentz describes the highlights from a 4/2 FDA Quality Management System Regulation town hall.
FDA posts a draft guidance outlining how drug developers should evaluate the safety of human gene therapies that use genome editing.
Medical device regulation expert Adrienne Lentz describes the highlights from a 4/2 FDA Quality Management System Regulation town hall.
FDA posts a draft guidance outlining how drug developers should evaluate the safety of human gene therapies that use genome editing.
FDA cites significant manufacturing and data integrity deficiencies at Hikal Limited following a 2/2025 inspection of the company’s active pharmaceutical ingredient facility in India.
FDA warns Philadelphia, PA-based Medical Products Laboratories about CGMP violations in its manufacturing of unapproved new drugs.
