lunes, 4 de enero de 2016

CDER SBIA Update: Novel New Drugs Summary 2015

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

Novel New Drugs Summary 2015
Today, the Food and Drug Administration released a summary of novel drugs approved by the agency’s Center for Drug Evaluation and Research (CDER) in calendar year 2015 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 2015, 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.

 Happy New Year from the CDER SBIA Team!

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