July 6, 2018

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Recent Posts

FDA Comments on Recently Released Rare Disease Guidance for Industry

September 16, 2015

Jonathan Goldsmith, M.D., F.A.C.P., FDA’s Associate Director, Rare Diseases Program, Center for Drug Evaluation and Research, comments on the recently...

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Featured Posts

2015 Novel New Drug Summary

January 5, 2016

The FDA recently released their 2015 Novel New Drug Summary.  While CDER will approve hundreds of new medications each year, many of these are variations on previously existing products.  Products in a small subset of these new approvals, that we refer to as novel new drugs, are among the more truly innovative products that often help advance clinical care to another level. At the end of each calendar year, CDER summarizes these new products.


This report highlights a special section for drugs for rare diseases.  47% of the novel new drugs approved in 2015 (21 of 45) were approved to treat rare or “orphan” diseases that affect 200,000 or fewer Americans.  


Check out the posting for more detail: 


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