Taking on Big Pharma and the FDA
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چکیده
Our American system of drug regulation is heavily frontloaded. The FDA spends a lot of time and energy (though not always enough) evaluating a proposed drug's safety and efficacy before approving it. But this initial evaluation is inherently constrained by the limited data available from clinical trials conducted before the product enters the marketplace. Ultimately, the FDA makes a judgment based on the limited data available about whether a drug should be approved.
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