A strategy for regulatory action when new adverse effects of a licensed product emerge.

@article{Aronson2009ASF,
  title={A strategy for regulatory action when new adverse effects of a licensed product emerge.},
  author={Jeffrey K Aronson and Deirdre Price and Robin E. Ferner},
  journal={Drug safety},
  year={2009},
  volume={32 2},
  pages={91-8}
}
Regulatory agencies grant product licences (marketing authorizations) for medicinal products in the light of evidence that the balance between benefit and harm in the population is favourable. Here we consider a framework for allowing regulatory agencies to make rational decisions when reviewing product licences in the light of new information about harms… CONTINUE READING