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

Orphan Drugs in 2016

January 26, 2017

The FDA Law Blog posted an informative article yesterday sharing insight into the status of the orphan drug landscape last year.  In 2016, both orphan drug approvals and designations decreased slightly; however, the number of orphan drug designation requests skyrocketed.  2016 was still the second best year for orphan drug designations, and the third best year for orphan drug approvals since the enactment of the Orphan Drug Act.

 

For a full analysis of designations, approvals, and requests, read the full article here: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2017/01/orphan-drug-approvals-and-designations-dipped-slightly-in-2016-but-orphan-drug-designation-requests-.html

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