Impact of expedited programs in the United States, as foreign regulatory factors, on clinical development time in Japan-Reference-Cited by-同舟云学术

Impact of expedited programs in the United States, as foreign regulatory factors, on clinical development time in Japan

Published:2022-04-30 Issue:9 Volume:47 Page:1395-1401
ISSN:0269-4727
Container-title:Journal of Clinical Pharmacy and Therapeutics
language:en
Short-container-title:Clinical Pharmacy Therapeu

Author:

Tajima Gentaro¹²^ORCID,Matsumaru Naoki¹^ORCID,Tsukamoto Katsura¹^ORCID

Affiliation:

1. Global Regulatory Science Gifu Pharmaceutical University Gifu Japan

2. Department of Regulatory Affairs Pfizer R&D Japan G.K Tokyo Japan

Publisher

Hindawi Limited

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/jcpt.13677

Reference32 articles.

1. How to improve R&D productivity: the pharmaceutical industry's grand challenge

2. Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018

3. Lessons from 60 years of pharmaceutical innovation

4. The Large Pharmaceutical Company Perspective

5. U.S. Food and Drug Administration.Guidance for industry: expedited programs for serious conditions—drugs and biologics.2014. Accessed July 3 2021.https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics.

Cited by 1 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Characteristics of Clinical Trials for the US Food and Drug Administration Accelerated Approval and Subsequent Confirmatory Trials: Implications for Drug Approval in Japan;Biological and Pharmaceutical Bulletin;2024-07-23