The opinions expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the Italian Medicines Agency or the Dutch Medicines Evaluation Board.
Letter to the Editors
Disclosure of grounds of European withdrawn and refused applications: a step forward on regulatory transparency
Article first published online: 15 MAR 2013
© 2012 The Authors. British Journal of Clinical Pharmacology © 2012 The British Pharmacological Society
British Journal of Clinical Pharmacology
Volume 75, Issue 4, pages 1149–1151, April 2013
How to Cite
Tafuri, G., Trotta, F., Leufkens, H. G. M. and Pani, L. (2013), Disclosure of grounds of European withdrawn and refused applications: a step forward on regulatory transparency. British Journal of Clinical Pharmacology, 75: 1149–1151. doi: 10.1111/j.1365-2125.2012.04424.x
- Issue published online: 15 MAR 2013
- Article first published online: 15 MAR 2013
- Accepted manuscript online: 15 AUG 2012 04:00AM EST
- Manuscript Accepted: 2 AUG 2012
- Manuscript Received: 28 APR 2012
Rate of efficacy, safety and quality deficiencies per therapeutic area. Legend: S, Q and E are related to Safety, Quality and Efficacy deficiencies respectively.
Query on disclosure of withdrawal and/or refused drug applications directed to a sample of drug regulatory authorities in various countries.
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