Literature DB >> 28379798

Regulatory Review of New Therapeutic Agents - FDA versus EMA, 2011-2015.

Nicholas S Downing1, Audrey D Zhang2, Joseph S Ross3.   

Abstract

Mesh：

Year:  2017        PMID： 28379798     DOI： 10.1056/NEJMc1700103

Source DB:  PubMed          Journal:  N Engl J Med        ISSN： 0028-4793            Impact factor:   91.245


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  14 in total

1.  A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs.

Authors:  Minette-Joëlle Zeukeng; Enrique Seoane-Vazquez; Pascal Bonnabry
Journal:  Eur J Clin Pharmacol       Date:  2018-02-22       Impact factor: 2.953

2.  Food and Drug Administration vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval.

Authors:  Roberta Joppi; Vittorio Bertele; Tommaso Vannini; Silvio Garattini; Rita Banzi
Journal:  Br J Clin Pharmacol       Date:  2019-12-16       Impact factor: 4.335

3.  Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019.

Authors:  Mark P Lythgoe; Aakash Desai; Bishal Gyawali; Philip Savage; Jonathan Krell; Jeremy L Warner; Ali Raza Khaki
Journal:  JAMA Netw Open       Date:  2022-06-01

4.  Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration.

Authors:  Huseyin Naci; Katelyn R Smalley; Aaron S Kesselheim
Journal:  JAMA       Date:  2017-08-15       Impact factor: 56.272

5.  Evaluation of Drug Trials in High-, Middle-, and Low-Income Countries and Local Commercial Availability of Newly Approved Drugs.

Authors:  Jennifer E Miller; Michelle M Mello; Joshua D Wallach; Emily M Gudbranson; Blake Bohlig; Joseph S Ross; Cary P Gross; Peter B Bach
Journal:  JAMA Netw Open       Date:  2021-05-03

6.  Why European and United States drug regulators are not speaking with one voice on anti-influenza drugs: regulatory review methodologies and the importance of 'deep' product reviews.

Authors:  Shai Mulinari; Courtney Davis
Journal:  Health Res Policy Syst       Date:  2017-11-09

Review 7.  Expanded access to investigational drugs: balancing patient safety with potential therapeutic benefits.

Authors:  Elena Fountzilas; Rabih Said; Apostolia M Tsimberidou
Journal:  Expert Opin Investig Drugs       Date:  2018-01-22       Impact factor: 6.206

8.  Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis.

Authors:  Mototsugu Tanaka; Mayumi Idei; Hiroshi Sakaguchi; Ryosuke Kato; Daisuke Sato; Kenji Sawanobori; Shuichi Kawarasaki; Toshiyuki Hata; Asako Yoshizaki; Miki Nakamura; Mutsuhiro Ikuma
Journal:  Clin Pharmacol Ther       Date:  2020-11-15       Impact factor: 6.875

Review 9.  Immune Checkpoint and Anti-Angiogenic Antibodies for the Treatment of Non-Small Cell Lung Cancer in the European Union and United States.

Authors:  Marion Ferreira; Thomas Secher; Nathalie Heuze-Vourc'H; Karen L Reckamp
Journal:  Pharmaceutics       Date:  2021-06-21       Impact factor: 6.321

10.  Pathways to ensure universal and affordable access to hepatitis C treatment.

Authors:  Caitlin H Douglass; Alisa Pedrana; Jeffrey V Lazarus; Ellen F M 't Hoen; Radi Hammad; Ricardo Baptista Leite; Andrew Hill; Margaret Hellard
Journal:  BMC Med       Date:  2018-10-09       Impact factor: 8.775
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