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

Gottlieb Plans to Streamline the Orphan Drug Review Process

June 22, 2017

FDA Commissioner Scott Gottlieb, MD, testified before a Senate Appropriations Subcommittee to discuss some of the programs he is implementing to streamline the FDA review process.  Gottlieb hopes to make orphan drugs easier to be reviewed by putting a stop to the requirement of companies to undertake new clinical trials for different disease subsets with the same drug.  

To read the full article and watch video on Gottlieb's testimony, please click on the following link: http://www.raredr.com/news/gottliebs-streamline-process

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