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Gabby Klein gives an overview of the P2P process, shedding light on the pitfalls with advice as to what we can do in protest ...
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FDA publishes A Draft Guidance for Industry - for serious conditions

Discussion in 'General ME/CFS News' started by Nielk, Jun 28, 2013.

  1. Nielk

    Nielk

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    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    FDA recently published a Draft Guidance for Industry on Expedited Programs for Serious Conditions--Drugs and Biologics.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
     
    WillowJ, Sean and Simon like this.

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