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Post-marketing drug withdrawals: pharmacovigilance success, regulatory problems : Arrêts de commercialisation de médicaments post-autorisation : succès de la pharmacovigilance, problèmes réglementaires

Abstract:

Modern pharmacovigilance began in the 1960s, since when the subject has grown markedly, interest having particularly increased since 2010. One index of its success is the increasing speed with which serious adverse drug reactions are discovered after marketing of a medicinal product. However, the speed with which products have subsequently been withdrawn as a result of the discovery of serious adverse reactions has not consistently changed. This highlights problems that regulators and manufac...

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Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.1016/j.therap.2017.02.005

Authors


More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Primary Care Health Sciences
Oxford college:
Green Templeton College
Role:
Author
ORCID:
0000-0003-1139-655X
Publisher:
Elsevier Publisher's website
Journal:
Thérapie Journal website
Volume:
72
Issue:
5
Pages:
555-561
Publication date:
2017-03-30
Acceptance date:
2017-03-05
DOI:
EISSN:
1958-5578
ISSN:
0040-5957
Pmid:
28461037
Language:
English
Keywords:
Pubs id:
pubs:846614
UUID:
uuid:a7075927-48dc-48f0-b32a-66c1f3182ae0
Local pid:
pubs:846614
Source identifiers:
846614
Deposit date:
2018-08-17

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