S22-1. Strategy of Drug Development to Approval in Exploratory Investigational New Drug Application: Introductory Remarks and Future Perspectives

2012 ◽  
Vol 43 (3) ◽  
pp. 187-188
Author(s):  
Chieko KURIHARA
Keyword(s):  
Drug Development ◽  
Drug Application ◽  
Future Perspectives ◽  
New Drug ◽  
New Drug Application ◽  
Investigational New Drug Application

scholarly journals FDA relations during drug development

2000 ◽  
Vol 2 (3) ◽  
pp. 213-217
Keyword(s):  
Drug Development ◽  
Drug Application ◽  
Development Program ◽  
The United States ◽  
Legal Aspects ◽  
Development Programs ◽  
New Drug ◽  
Regulatory Affairs ◽  
New Drug Application ◽  
Drug Development Program

Working closely and cooperatively with regulatory authorities during drug development is vital to successful drug development programs. In the United States, the drug development team includes not only members of the key disciplines of drug discovery, clinical research, regulatory affairs, marketing, chemistry, toxicology, and legal aspects, but also the Food and Drug Administration (FDA). New regulations encourage meetings at the pre-investigational new drug (pre-IND), end-of-phase-2, and pre-new drug application (pre-NDA) submission phases. Appropriate informal discussions via fax and telephone are also encouraged. By proactively interacting with the FDA, the pharmaceutical industry increases the probability of a successful drug development program.

Streamlining nonclinical drug development using the FDA 505(b)(2) new drug application regulatory pathway

2019 ◽  
Vol 24 (1) ◽  
pp. 46-56
Author(s):  
William F. Salminen ◽  
Marc E. Wiles ◽  
Ruth E. Stevens
Keyword(s):  
Drug Development ◽  
Drug Application ◽  
Regulatory Pathway ◽  
New Drug ◽  
New Drug Application

scholarly journals Assessing Animal Models of Bacterial Pneumonia Used in Investigational New Drug Applications for the Treatment of Bacterial Pneumonia

2020 ◽  
Vol 64 (5) ◽  
Author(s):  
Ursula Waack ◽  
Edward A. Weinstein ◽  
John J. Farley
Keyword(s):  
Animal Models ◽  
Bacterial Pneumonia ◽  
Drug Application ◽  
Design Elements ◽  
New Drug ◽  
Regulatory Submissions ◽  
Human Use ◽  
New Drug Application ◽  
Investigational New Drug Application

ABSTRACT Animal models of bacterial infection have been widely used to explore the in vivo activity of antibacterial drugs. These data are often submitted to the U.S. Food and Drug Administration to support human use in an investigational new drug application (IND). To better understand the range and scientific use of animal models in regulatory submissions, a database was created surveying recent pneumonia models submitted as part of IND application packages. The IND studies were compared to animal models of bacterial pneumonia published in the scientific literature over the same period of time. In this review, we analyze the key experimental design elements, such as animal species, immune status, pathogens selected, and route of administration, and study endpoints.

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