FDA accepts for review a Liquidia Technologies 505(b)(2) NDA for LIQ861 (treprostinil) for treating pulmonary arterial hypertension.
Federal Register notice: FDA posts a user fee-related report providing options and recommendations for a new methodology to assess changes in the reso...
Federal Register notice: FDA postpones a 4/21-planned Pulmonary-Allergy Drugs Advisory Committee meeting that was scheduled to discuss a GlaxoSmithKli...
FDA warns Romanias Global Treat Srl about CGMP violations in its production of finished drugs.
Three stakeholders tell what they like about an FDA draft guidance on biosimilar promotional advertising and labeling.
FDA says it will exercise enforcement discretion for some ophthalmic assessment and monitoring devices during the coronavirus pandemic.
A Society of Corporate Compliance and Ethics white paper recommends ways to build a resilient healthcare supply chain once the coronavirus pandemic ha...
FDA warns Hungarys Mandelay Kft about Quality System violations in its manufacturing of two medical devices.