A new approach to psychiatric drug approval in Europe.
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ABSTRACT:
SUBMITTER: Barbui C
PROVIDER: S-EPMC3797138 | biostudies-literature | 2013 Oct
REPOSITORIES: biostudies-literature
Publications
A new approach to psychiatric drug approval in Europe.
Barbui Corrado C Bighelli Irene I
PLoS medicine 20131015 10
Corrado Barbui and Irene Bighelli question the current rules governing registration of new medicines in Europe, using the example of psychiatric drugs, and argue that the concept of absolute efficacy should be replaced by the concept of added value whereby evidence from studies comparing a new product with an active comparator should guide the drug approval process. Please see later in the article for the Editors' Summary. ...[more]
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