Moving new vaccines for tuberculosis through the regulatory process.
The development of novel vaccines for the prevention of tuberculosis is an area of intense interest for scientific researchers, public health agencies, and pharmaceutical manufacturers. Development of effective new vaccines directed against tuberculosis for use in target populations will require close cooperation among several different international organizations, including regulatory agencies responsible for evaluating the safety and effectiveness of new biologics for human use.
Brennan
M J
MJ
Laboratory of Mycobacteria, Center for Biologics Evaluation and Research, US Food and Drug Administration, Bethesda, MD 20892, USA. Brennan@cber.fda.gov.
D000818:Animals; D001500:BCG Vaccine / Q000008:administration & dosage / Q000276:immunology / Q000592:standards; D001428:Bacterial Vaccines / Q000008:administration & dosage / Q000276:immunology / Q000592:standards; D002986:Clinical Trials as Topic; D017277:Drug Approval; D006801:Humans; D009169:Mycobacterium tuberculosis / Q000276:immunology*; D009316:National Institutes of Health (U.S.); D014397:Tuberculosis, Pulmonary / Q000517:prevention & control*; D014481:United States; D014486:United States Food and Drug Administration
D001500:BCG Vaccine; D001428:Bacterial Vaccines