CDER New March 31, 2016

What's New on the FDA Drugs Site

March 30, 2016

• FDA announces voluntary recall of all unexpired human and animal compounded drug products produced by Reliable Drug Pharmacy, San Francisco 
• Drugs@FDA Data Files (updated
• FDA approves Defitelio (defibrotide sodium), first treatment for rare disease in patients who receive stem cell transplant from blood or bone marrow
• Medication Guides Page (updated)
• Paragraph IV Patent Certifications (updated)
• FDA Drug Safety Communication (Spanish): La FDA advierte de varios problemas de seguridad con los analgésicos opiáceos y exige cambios a la etiqueta