Literature DB >> 28465401

Conditional approval of medicines by the EMA.

Rita Banzi1, Chiara Gerardi2,2, Vittorio Bertele'2, Silvio Garattini2.   

Abstract

Year:  2017        PMID： 28465401     DOI： 10.1136/bmj.j2062

Source DB:  PubMed          Journal:  BMJ        ISSN： 0959-8138


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  4 in total

1.  Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis.

Authors:  Huseyin Naci; Courtney Davis; Jelena Savović; Julian P T Higgins; Jonathan A C Sterne; Bishal Gyawali; Xochitl Romo-Sandoval; Nicola Handley; Christopher M Booth
Journal:  BMJ       Date:  2019-09-18

2.  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.

Authors:  Catherine Schuster Bruce; Petra Brhlikova; Joseph Heath; Patricia McGettigan
Journal:  PLoS Med       Date:  2019-09-10       Impact factor: 11.069

3.  Pre-approval and post-approval availability of evidence and clinical benefit of conditionally approved cancer drugs in Europe: A comparison with standard approved cancer drugs.

Authors:  Lourens T Bloem; Rosa E Bot; Aukje K Mantel-Teeuwisse; Menno E van der Elst; Gabe S Sonke; Olaf H Klungel; Hubert G M Leufkens; Jarno Hoekman
Journal:  Br J Clin Pharmacol       Date:  2022-01-05       Impact factor: 3.716

4.  Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs.

Authors:  Rick A Vreman; Jacoline C Bouvy; Lourens T Bloem; Anke M Hövels; Aukje K Mantel-Teeuwisse; Hubert G M Leufkens; Wim G Goettsch
Journal:  Clin Pharmacol Ther       Date:  2018-11-08       Impact factor: 6.875
  4 in total

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