Advancing TB vaccines to Phase I clinical trials in the US: regulatory/manufacturing/licensing issues

This article discusses the steps required to file an investigational new drug (IND) application to the United States Food and Drug Administration (FDA) and begin a Phase I trial of a new tuberculosis vaccine in the US. Many different groups play a role in bringing a new vaccine to market. But it is...

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Bibliographic Details
Published in:Tuberculosis (Edinburgh, Scotland) Scotland), 2005-01, Vol.85 (1), p.39-46
Main Authors: Rowland, Sharon S., Mayner, Ronald L., Barker, Lewellys
Format: Article
Language:English
Subjects:
Animals
Clinical Trial
Clinical Trials, Phase I as Topic - legislation & jurisprudence
Clinical Trials, Phase I as Topic - standards
Drug Design
Drug Evaluation - methods
Drug Industry - legislation & jurisprudence
Drug Industry - standards
Humans
Licencing
Licensure
Manufacturing
Recombinant Proteins - therapeutic use
Regulation
Tuberculosis
Tuberculosis - prevention & control
Tuberculosis Vaccines - therapeutic use
United States
United States Food and Drug Administration - organization & administration
Vaccine
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Summary:This article discusses the steps required to file an investigational new drug (IND) application to the United States Food and Drug Administration (FDA) and begin a Phase I trial of a new tuberculosis vaccine in the US. Many different groups play a role in bringing a new vaccine to market. But it is the researcher who begins the process by converting an idea into a new vaccine construct. Awareness of certain chemistry, manufacturing, and control (CMC) issues on the part of the researcher who develops the investigational vaccine can prevent later problems that might cause the vaccine to be unapprovable or fail to meet regulatory requirements for eventual licensure. CMC information included in an IND is described.
ISSN:1472-9792
1873-281X
DOI:10.1016/j.tube.2004.09.012