Development of new tuberculosis vaccines: a global perspective on regulatory issues

PLoS Med. 2007 Aug;4(8):e252. doi: 10.1371/journal.pmed.0040252.

Authors

Michael J Brennan¹, Uli Fruth, Julie Milstien, Rosemary Tiernan, Sergio de Andrade Nishioka, Liliana Chocarro; Developing Countries Vaccine Regulatory Network and the Ad Hoc Regulatory and TB Expert Panel

Affiliation

¹ Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland, United States of America. Michael.Brennan@fda.hhs.gov

Abstract

What are the regulatory challenges for testing and introducing investigative TB vaccines into countries where the disease is endemic?

MeSH terms

Clinical Trials as Topic / legislation & jurisprudence*
Drug Approval / legislation & jurisprudence*
Global Health
Humans
Mycobacterium tuberculosis / immunology
Public Policy
Tuberculosis / immunology
Tuberculosis / microbiology
Tuberculosis / prevention & control*
Tuberculosis / transmission
Tuberculosis Vaccines* / immunology
Tuberculosis Vaccines* / standards

Substances

Tuberculosis Vaccines