FDA warns Argentinas Terragene S.A. about Quality System violations in its manufacturing of Biological and Chemical Sterilization Process Indicator Sy...
FDA warns Avcilar/Istanbul, Turkey-based Sudesan Temizlik Urunleri Ve Ambalaj Sanaryi Ticaret Anomin Sirketi about CGMP violations in its production o...
FDA warns Anish Shah, doing business as Siyan Clinical Research in Santa Rosa, CA, about not following the investigational plan for a clinical investi...
FDA commissioner Robert Califf says the agency recently published three additional guidances to help advance the use of real-world data and real-world...
FDA publishes a guidance on assessing registries to support drug and biologic regulatory decision-making as part of its real-world evidence program.
FDA says ResMed has issued updated instructions for its masks with magnets to inform users about potential magnetic interference when magnets are near...
FDA publishes a guidance to assist sponsors in conducting efficient and successful drug development programs to treat rare diseases.
FDA publishes a draft guidance making recommendations on the design and analysis of drug development trials conducted under a master protocol.
