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- Title
Appropriate evidence for adaptive marketing authorization.
- Authors
de Jong, Jean Philippe; Grobbee, Diederick E.; Flamion, Bruno; Forda, Susan R.; Leufkens, Hubert G. M.
- Abstract
The authors focus on the four components of the marketing authorization for a drug. The authors mention that the confidence of the regulators and the public in the benefit-risk balance of a drug can be achieved by a thorough analysis of clinical trials. They say that additional stakeholders can be included in the discussion on marketing authorization. They add that the adaptability of the regulatory system is also needed.
- Subjects
DRUG marketing; DRUG approval; CLINICAL trials; STAKEHOLDERS; CONFIDENCE; GOVERNMENT policy
- Publication
Nature Reviews Drug Discovery, 2013, Vol 12, Issue 9, p647
- ISSN
1474-1776
- Publication type
Article
- DOI
10.1038/nrd4114