The Food and Drug Administration (FDA)

pharmafile | October 1, 2010 | News story | |  FDA, Food and Drug Administration 

The current incarnation of the Food and Drug Administration (FDA) was established in 1930, but the US regulator’s modern functions began with the passage of the 1906 Pure Food and Drugs Act.

The FDA is a centralised federal office that regulates the marketplace for food and prescription drugs in America.

Drug safety and efficacy is assessed using evidence-based clinical trial data and in recent years the FDA has stepped up its efforts to assess phase IV, or ‘post-marketing’, trial data.

The FDA does not have the remit to assess a drug’s cost-effectiveness and will not take this into consideration during a drug’s assessment.

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The body does have the power to order a drug’s removal from the market or change its safety label if it is proven to not be clinically effective or safe.

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