A Comparison ofEMAandFDADecisions for New Drug Marketing Applications 2014–2016: Concordance, Discordance, and Why-Reference-Cited by-同舟云学术

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A Comparison ofEMAandFDADecisions for New Drug Marketing Applications 2014–2016: Concordance, Discordance, and Why

Published:2019-08-14 Issue:1 Volume:107 Page:195-202
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Kashoki Mwango¹²,Hanaizi Zahra³,Yordanova Stella³,Veselý Richard³,Bouygues Christelle³,Llinares Jordi³,Kweder Sandra L.⁴^ORCID

Affiliation:

1. Office of New Drugs Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

2. PAREXEL Consulting PAREXEL International Billerica Massachusetts USA

3. Scientific and Regulatory Management Department Human Medicines Evaluation Division European Medicines Agency Amsterdam The Netherlands

4. Europe Office Office of Global Policy and Strategy US Food and Drug Administration Silver Spring Maryland USA

Funder

U.S. Food and Drug Administration

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1565

Reference19 articles.

1. The ICH, the GHTF, and the future of harmonization initiatives;Tominaga T.;Ther. Innov. Sci.,2013

2. Regulatory Review of New Therapeutic Agents — FDA versus EMA, 2011–2015

3. Cross-Comparison of Cancer Drug Approvals at Three International Regulatory Agencies

4. Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?

5. Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012

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