A strategy for regulatory action when new adverse effects of a licensed product emerge.
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 pro...
| Main Authors: | , , |
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| Format: | Journal article |
| Jezik: | English |
| Izdano: |
2009
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