Tag Archives: FDA Fast Track Development Program

Rare Diseases Deserve Access to Accelerated Approval – Call Congress TODAY!

Rare Diseases Deserve Access to Accelerated Approval – Call Congress TODAY!
http://www.congressweb.com
The FDA recently issued a draft guidance on the Expedited Approval Programs which they say fulfills the FDASIA mandate on Accelerated Approval for Rare Diseases, however the guidance does not address specific issues related to rare disease drug development as required by FDASIA. This is unacceptable! Continue reading

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