The decision-making process of US Food and Drug Administration advisory committees on switches from prescription to over-the-counter status: a comparative case study.

@article{Nguyen2006TheDP,
  title={The decision-making process of US Food and Drug Administration advisory committees on switches from prescription to over-the-counter status: a comparative case study.},
  author={Nancy Thai Nguyen and Daniel M. Cook and Lisa A. Bero},
  journal={Clinical therapeutics},
  year={2006},
  volume={28 8},
  pages={1231-1243}
}
BACKGROUND The US Food and Drug Administration (FDA) and FDA advisory committees have been under increasing scrutiny as a result of media attention to safety concerns. OBJECTIVE This article compares the decision-making process of the FDA's Nonprescription Drugs Advisory Committee (NDAC) in 3 cases of a proposed switch from prescription to over-the-counter (OTC) status involving a nicotine replacement therapy product, 2 statins, and an emergency oral contraceptive. METHODS This comparative… CONTINUE READING

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