A new approach to psychiatric drug approval in Europe.
editorial · Level V
Where this comes from
- Record sourced from PubMed, PMID 24143137.
- Also identified by DOI 10.1371/journal.pmed.1001530 and PMC identifier 3797138.
- Licence recorded as CC BY.
- The licence permits redistribution, so the abstract is shown in full and the full text is available from the publisher.
Abstract
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.
Medical subject headings
- Drug Approval