The use of validated and nonvalidated surrogate endpoints in two European Medicines Agency expedited approval pathways: A cross-sectional study of products authorised 2011

The use of validated and nonvalidated surrogate endpoints in two European Medicines Agency expedited approval pathways: A cross-sectional study of products authorised 2011–2018

Published:2019-09-10 Issue:9 Volume:16 Page:e1002873
ISSN:1549-1676
Container-title:PLOS Medicine
language:en
Short-container-title:PLoS Med

Author:

Schuster Bruce Catherine,Brhlikova Petra^ORCID,Heath Joseph,McGettigan Patricia^ORCID

Publisher

Public Library of Science (PLoS)

Subject

General Medicine

Reference107 articles.

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3. European Medicines Agency. Conditional Marketing Authorisation. Available from: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/conditional-marketing-authorisation. [cited 2019 Aug 19].

4. The Commission of the European Communities. Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council. Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2006_507/reg_2006_507_en.pdf. [cited 2019 Aug 19].

5. European Medicines Agency. Accelerated Assessment. Available from: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/accelerated-assessment. [cited 2019 Aug 19].

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