FDA issues an updated compliance program that standardizes how inspectors evaluate manufacturing facilities tied to biologic drug applications.
FDA warns Philadelphia, PA-based Medical Products Laboratories about CGMP violations in its manufacturing of unapproved new drugs.
FDA warns Livonia, MI-based Purolea Cosmetics Lab about CGMP and other violations in its production of finished drugs as a contractor.
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FDA posts a draft guidance outlining how drug developers should evaluate the safety of human gene therapies that use genome editing.
Exelixis petitions FDA to require Handa Pharmaceuticals and others submitting a 505(b)(2) NDA for a caboztinib product referencing Exelixis Cabometyx ...
Three McDermott attorneys outline the key elements in an FDA 3/2026 guidance that helps establishments respond to an FDA-483.
FDA cites significant manufacturing and data integrity deficiencies at Hikal Limited following a 2/2025 inspection of the companys active pharmaceutic...
