Oncologic orphan drugs approved in the EU – do clinical trial data correspond with real-world effectiveness?-Reference-Cited by-同舟云学术

Oncologic orphan drugs approved in the EU – do clinical trial data correspond with real-world effectiveness?

Published:2018-11-28 Issue:1 Volume:13 Page:
ISSN:1750-1172
Container-title:Orphanet Journal of Rare Diseases
language:en
Short-container-title:Orphanet J Rare Dis

Author:

Schuller Yvonne,Biegstraaten Marieke,Hollak Carla E. M.,Klümpen Heinz-Josef,Gispen-de Wied Christine C.,Stoyanova-Beninska Violeta

Funder

College ter Beoordeling van Geneesmiddelen

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Genetics (clinical),General Medicine

Link

http://link.springer.com/content/pdf/10.1186/s13023-018-0900-9.pdf

Reference65 articles.

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3. Putzeist M, Mantel-Teeuwisse AK, Llinares J, et al. EU marketing authorization review of orphan and non-orphan drugs does not differ. Drug Discov Today. 2013;18(19-20):1001–6.

4. Guideline on the evaluation of anticancer medicinal products in man. European Medicines Agency; 2012. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/01/WC500137128.pdf . Accessed 14 Mar 2016.

5. Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. Food and Drug Administration. http://www.fda.gov/downloads/Drugs/Guidances/ucm071590.pdf . Accessed 14 Mar 2016.

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