scholarly journals DMF FILING IN US, EUROPE AND CANADA

2018 ◽  
Vol 3 (4) ◽  
pp. 9-17
Author(s):  
Pooja Agarwal ◽  
J. K. Badjatya
Keyword(s):  
Drug Product ◽  
Drug Application ◽  
Reference Source ◽  
Specific Process ◽  
New Drug ◽  
Animal Use ◽  
Human Animal ◽  
New Drug Application ◽  
Investigational New Drug Application ◽  
Product Manufacturer

A Drug Master File or DMF is a reference source that provides drug evaluator’s confidential information not available to drug product manufacturer about the specific process and components used in the manufacturing, processing and packaging of a drug meant for Human/Animal use. The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, or amendments and supplements to any of these.

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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