Nielk
Senior Member
- Messages
- 6,970
I just received this e-mail:
FDA recently published a Draft Guidance for Industry on Expedited Programs for Serious Conditions--Drugs and Biologics.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
FDA recently published a Draft Guidance for Industry on Expedited Programs for Serious Conditions--Drugs and Biologics.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