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28 juni 2013 - FDA Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics


FDA Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics

FDA recently published a Draft Guidance for Industry on Expedited Programs for Serious Conditions--Drugs and Biologics. This is important to the CFS community because FDA has designated CFS as a serious disease, so provided a product is treating a serious aspect of the disease, these pathways may apply. Specifically, the guidance outlines expedited programs available for qualifying products, including fast track designation, breakthrough therapy designation, accelerated approval, and priority review. 


The full guidance may be found at the following link:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf


Source : National Institutes of Health



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