Journal article icon

Journal article

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

Abstract:

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 that change that balance. The regulator can revoke the product licence, restrict the product's availability or change the 'label' in differ...

Expand abstract
Publication status:
Published

Actions


Access Document


Authors


More by this author
Institution:
University of Oxford
Department:
Oxford, MSD, Primary Care Health Sciences, PHC-Seniors
Role:
Author
Journal:
Drug safety
Volume:
32
Issue:
2
Pages:
91-98
Publication date:
2009-01-01
DOI:
ISSN:
0114-5916
URN:
uuid:39d0aebd-4920-4c61-abd5-6d819e768717
Source identifiers:
116989
Local pid:
pubs:116989

Terms of use


Metrics


Views and Downloads






If you are the owner of this record, you can report an update to it here: Report update to this record

TO TOP