This film tells the story of a medical drug scandal and its heroine from both a scientific and political perspective. When Frances Kelsey, a pharmacologist and physician working at the FDA, was assigned to review the application for the drug Thalidomide, the process became a drama unto itself when she discovered that the testing processes of the drug had been falsified. By denying FDA approval, Kelsey prevented scores of thousands of babies from being born with severe deformities and saved an equally high number of users from suffering other irreparable side effects. Her tenacity resulted in higher standards for drug research and a stiffening of US drug laws. As a result, the process of halting faulty clinical studies quickly is now applied internationally.
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