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 2016 as new molecular entities or as new therapeutic biologics. Novel 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 drug approvals decreased in 2016, our focus continues to be on the unique medical value 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: NovelDrugs
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.
Email: CDERSBIA@fda.hhs.gov
Phone: 1-866-405-5367
Phone: (301) 796-6707
Website: http://www.fda.gov/cdersbia
Phone: 1-866-405-5367
Phone: (301) 796-6707
Website: http://www.fda.gov/cdersbia
Please take our CDER SBIA survey: https://www.surveymonkey.com/
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