The Power and Pitfalls of Omics: George Davey Smith’s storming talk at ME/CFS conference
Read about the talk that stole the show at a recent ME/CFS conference in Simon McGrath's two-part blog.
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A Dual-Track Drug Approval Process

Discussion in 'General Treatment' started by MikeJackmin, Dec 2, 2015.

  1. MikeJackmin

    MikeJackmin Senior Member

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    Interesting proposal:

    "FTCM legislation in the U.S. would create a dual track system (see figure below) that preserves the existing FDA clinical trial process while offering patients an alternative. Patients, advised by their doctors, would be able to contract with a drug developer to use not-yet-approved drugs after Phase I safety trials are successfully completed and one or more Phase II trials have demonstrated continued safety and initial efficacy. The resulting early access could make FTCM drugs available up to seven years before conventional FDA approval, which entails Phase III randomized control trials and a lengthy FDA review before the FDA makes an approval decision."

    A Dual-Track Drug Approval Process
     
    trails likes this.

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