CDER New May 31, 2013

What's New on the FDA Drugs Site
May 30, 2013

• FDA Drug Safety Communication: FDA Drug Safety Communication: FDA Recommends Against Prolonged Use of Magnesium Sulfate to Stop Pre-term Labor Due to Bone Changes in Exposed Babies
• Clinical Development Programs for Opioid Conversion; Public Workshop; Request for Comments, July 29, 2013, FDA White Oak Campus, Bldg. 31, The Great Room, (Rm 1503), Silver Spring, MD. Meeting information
• Current Drug Shortages Index (updated)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Guidance for Industry:  Rheumatoid Arthritis: Developing Drug Products for Treatment (PDF - 177KB)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (FDASIA) (updated)
• MedWatch Safety Alert: Magnesium Sulfate Injection by Fresenius Kabi USA: Recall - Glass Particles in Vials
• MedWatch Safety Alert: Olympia Pharmacy Sterile Compounded Products: Recall - Concerns About Sterility Assurance
• National Drug Code Directory
• Spanish Drug Safety Communication: Sulfato de magnesio - FDA recomienda que no se use el sulfato de magnesio por periodos prolongados para detener partos prematuros debido a cambios en los huesos de los bebés expuestos