The FDA Roadblock to Cures

  title={The FDA Roadblock to Cures},
  author={Paul J. Marangos},
The Food and Drug Administration (FDA) has evolved to become a major impediment to drug availability, especially for terminal disease patients. It has made drug approval a 10- to 12-year process that can cost as much as 2 billion dollars to accomplish. The entire regulatory path to drug approval is described as well as the statistical metrics mandated by the FDA. Clinical science is not precise given the extreme variation in the human population yet the FDA treats it as an exact science… CONTINUE READING

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