Sunday, December 5, 2010

Accelerating orphan drug development

Nature Reviews Drug Discovery 9, 901-902 (December 2010) | doi:10.1038/nrd3340

Timothy R. Coté, Kui Xu & Anne R. Pariser

"Given the limited resources available for rare disease R&D, it is imperative that all knowledge gained is used to maximum benefit at each phase.
The FDA is committed to accelerating orphan drug development through a regulatory system built on integrity, consistency and transparency; a system that has delivered benefits to people who desperately need them and promises to deliver much more."