"Black box" 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk.

@article{Murphy2006BlackB1,
  title={"Black box" 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk.},
  author={Shirley Murphy and Rosemary Roberts},
  journal={The Journal of allergy and clinical immunology},
  year={2006},
  volume={117 1},
  pages={34-9}
}
A prominently displayed boxed warning, the so-called "black box," is added to the labeling of drugs or drug products by the Food and Drug Administration when serious adverse reactions or special problems occur, particularly those that may lead to death or serious injury. Healthcare providers are often not knowledgeable about the origin, meaning, and implications of these "black box" warnings. In this review, our goal is to provide insight into how the Food and Drug Administration evaluates… CONTINUE READING

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