When EMA and FDA decisions conflict: differences in patients or in regulation?

@article{Wolfe2013WhenEA,
  title={When EMA and FDA decisions conflict: differences in patients or in regulation?},
  author={Sidney M. Wolfe},
  journal={BMJ : British Medical Journal},
  year={2013},
  volume={347}
}
  • S. Wolfe
  • Published 22 August 2013
  • Medicine
  • BMJ : British Medical Journal
In his new regular column Sid Wolfe asks why the two regulatory bodies have arrived at different decisions on the same diet drugs 
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13 Citations
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13 Citations

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Citation Type

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New drug targets have been identified in brown adipose tissue with the aim of not only activating thermogenesis but also increasing the capacity for thermogenesis in this tissue.
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The goal of this review will be to present the current evidence for the medications approved for adolescents, medications notapproved for adolescents but have adolescent data, and medications approved by the Food and Drug Administration with the prospect for use in adolescents.
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Current Perspectives on Long-term Obesity Pharmacotherapy.
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    Canadian journal of diabetes
  • 2016
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The robustness of these findings are called into question by the results of an interaction analysis which of observed no significant difference between placebo control and intervention groups over time for these outcomes.
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Two new oral agents—phentermine and extended release (ER) topiramate ( Qsymia ) and lorcaserin ( Belviq )—were approved by the US Food and Drug Administration as adjuvants to health behaviour modification in patients with a BMI of greater than 30 or greater than 27 if they also had an obesity related comorbidity, such as hypertension, dyslipidaemia, or type 2 diabetes.
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