Review: 'Through the Shadowlands’ describes Julie Rehmeyer's ME/CFS Odyssey
I should note at the outset that this review is based on an audio version of the galleys and the epilogue from the finished work. Julie Rehmeyer sent me the final version as a PDF, but for some reason my text to voice software (Kurzweil) had issues with it. I understand that it is...
Discuss the article on the Forums.

A Dual-Track Drug Approval Process

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

  1. MikeJackmin

    MikeJackmin Senior Member

    Messages:
    132
    Likes:
    449
    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.

See more popular forum discussions.

Share This Page