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? asked in HealthDiseases & ConditionsCancer · 6 years ago

If you were the goverment, how fast could you push a drug through the FDA?

Say they discovered a cure for cancer. How fast could they fast track the drug through the process ??5 years???

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  • 6 years ago
    Favorite Answer

    The FDA has a program known as the "Breakthrough Therapy Designation." "A breakthrough therapy is a drug intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.

    "If a drug is designated as breakthrough therapy, FDA will expedite the development and review of such drug. All requests for breakthrough therapy designation will be reviewed within 60 days of receipt, and FDA will either grant or deny the request. " http://www.fda.gov/RegulatoryInformation/Legislati...

    A breakthrough therapy designation does not mean a shortened time of testing (Phase 1 trials are tightly regulated), but will expedite the time needed to review results.

    An example of an approval that used this FDA Breakthrough Approval Designation is Ibrance (palbociclib). Research on Ibrance began in 2007 and breakthrough/fastrack status was granted to Pfizer in 2013. The drug was approved in early 2015. http://www.sciencedaily.com/releases/2015/02/15020...

    Note ... it still took over seven years for approval ... but it's faster than the most standard times of 10 - 20 years, depending upon research, etc.

  • 6 years ago

    Generally it takes 10 to 15 years for a drug to undergo full safety and dosage testing.

    I would be appalled by anyone trying to speed up the process, peoples lives depend on these long term tests.

  • april
    Lv 7
    6 years ago

    You think the govt is the brains of the operation? lol

  • Mr E
    Lv 7
    6 years ago

    how naive. never gonna happen.

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