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

Regulatory Flexibility and Lessons Learned in Orphan Drug Development

October 26, 2016

John Jenkins, MD, Director, Office of New Drugs at FDA spoke at the NORD Summit last week about the regulatory flexibility granted to drugs being developed to treat rare diseases.  In his presentation, he shares his own personal opinions about the recent approval for eteplirsen and what other companies should and shouldn't do to gain drug approval.

 

A link to his full presentation may be found here: http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM525805.pdf

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