- Andrew Grey, associate professor1,
- Kirin Tan, medical student1,
- Keith J Petrie, professor2,
- Kate Faasse, postdoctoral fellow2,
- Mark J Bolland, associate professor1
- 1Department of Medicine, University of Auckland, Private Bag 92019, Auckland, New Zealand
- 2Department of Psychological Medicine, University of Auckland, Private Bag 92019, Auckland, New Zealand
- a.grey{at}auckland.ac.nz
MacDonald discusses the importance of the summary of product characteristics, a document prepared by companies seeking marketing approval for their drugs, to presentation of information about adverse drug reactions by a regulatory authority.1 2 The inclusion in this summary of any adverse reaction …
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