jueves, 15 de enero de 2015

CDER SBIA Update: 2014 New Molecular Entities and New Therapeutic Biological Products

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

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

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.

Please take our CDER Small Business survey: https://www.surveymonkey.com/s/CDERSBIA_Evaluation

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