2014 Novel New Drugs
1. CDER’s New Molecular Entities and New Therapeutic Biological Products
FDA posted a summary of novel new drugs approved in calendar year (CY) 2014 as new molecular entities under new drug applications or as new therapeutic biologics under biologics license applications. Novel new drugs are often innovative products that serve previously unmet medical needs potentially adding significant clinical value to the care of thousands of patients – many with serious and life-threatening diseases. While the quantity of novel new drug approvals increased in CY 2014, our main focus continues to be on the unique qualities of many of these new drugs, their contribution to enhanced patient care, and the various regulatory tools the Agency employed to ensure their safe and efficient development and approval.
For more information, please visit: NovelNewDrugs
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