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

• 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
• ISSN: 1472-9792; 1873-281X
• DOI: 10.1016/j.tube.2004.09.012

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.