Nature Search

European regulatory experience with drugs for central nervous system disorders

Butlen-Ducuing and colleagues analyse ~20 years of data on regulatory applications assesssed by the European Medicines Agency in psychiatry and neurology, with the aim of illuminating challenges that underlie the 'pipeline problem' for drugs for central nervous system disorders.

Florence Butlen-Ducuing
Malgorzata Zienowicz
Guido Rasi
Comments & Opinion19 Dec 2014
Nature Reviews Drug Discovery

Volume: 14, P: 89-90
DSM-5 and clinical trials in psychiatry: challenges to come?

Florence Butlen-Ducuing
Manuel Haas
Karl Broich
Comments & Opinion01 Aug 2012
Nature Reviews Drug Discovery

Volume: 11, P: 583-584
Challenges in drug development for central nervous system disorders: a European Medicines Agency perspective

Florence Butlen-Ducuing
Frank Pétavy
Enrica Alteri
News29 Nov 2016
Nature Reviews Drug Discovery

Volume: 15, P: 813-814
Implications of sex-related differences in central nervous system disorders for drug research and development

Research on sex differences in central nervous system disorders has developed substantially in recent years. Here, we discuss selected examples and the implications for drug development.

Florence Butlen-Ducuing
Ewa Balkowiec-Iskra
Antonella Santuccione Chadha
Comments & Opinion05 Jul 2021
Nature Reviews Drug Discovery

Volume: 20, P: 881-882
Digital health technologies in clinical trials for central nervous system drugs: an EU regulatory perspective

Digital health technologies have the potential to help address some of the challenges in the clinical development of drugs for central nervous system disorders. This article discusses strategies for the development of such tools in the context of the European regulatory environment.

Valentina Mantua
Celso Arango
Florence Butlen-Ducuing
Comments & Opinion29 Sept 2020
Nature Reviews Drug Discovery

Volume: 20, P: 83-84
The European Medicines Agency's strategies to meet the challenges of Alzheimer disease

Regulatory agencies have a key role in facilitating the development of new drugs for Alzheimer disease, particularly given the challenges associated with early intervention. Here, we summarize the strategies of the European Medicines Agency to help address such challenges.

Manuel Haas
Valentina Mantua
Karl Broich
Comments & Opinion01 Apr 2015
Nature Reviews Drug Discovery

Volume: 14, P: 221-222
Precision psychiatry roadmap: towards a biology-informed framework for mental disorders

Martien J. H. Kas
Brenda W. J. H. Penninx
Valentina Mantua
ReviewsOpen Access19 Jun 2025
Molecular Psychiatry

Volume: 30, P: 3846-3855
A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials

Luca Sforzini
Courtney Worrell
Carmine M. Pariante
ReviewsOpen Access15 Dec 2021
Molecular Psychiatry

Volume: 27, P: 1286-1299

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