Novel licensure pathways for expeditious introduction of new tuberculosis vaccines: A discussion of the adaptive licensure concept

Tuberculosis

Volumn 94, Issue 2, 2014, Pages 178-182

  Rustomjee, Roxana ^a,b   Lockhart, Stephen ^b   Shea, Jacqueline ^c   Fourie, P Bernard ^d   Hindle, Zoë ^b   Steel, Gavin ^e   Hussey, Gregory ^f   Ginsberg, Ann ^g   Brennan, Michael J ^h  

^a SOUTH AFRICAN MEDICAL RESEARCH COUNCIL   (South Africa)

^b Emergent Biosolutions   (United Kingdom)

^c Medawar Centre   (United Kingdom)

^d UNIVERSITY OF PRETORIA   (South Africa)

^e Medicines Control Council   (South Africa)

^f UNIVERSITY OF CAPE TOWN   (South Africa)

^g AERAS   (United States)

^h Global Affairs   (United States)

Author keywords

Licensure; Regulatory; Strategy; Tuberculosis; Vaccines

Indexed keywords

BCG VACCINE; BEDAQUILINE; DELAMANID; MENINGOCOCCUS VACCINE;

DRUG APPROVAL; DRUG EFFICACY; DRUG MARKETING; DRUG SAFETY; HUMAN; IMMUNOGENICITY; LICENSING; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SOUTH AFRICA; TUBERCULOSIS; DRUG DESIGN; FEMALE; MALE; ORGANIZATION AND MANAGEMENT; PRACTICE GUIDELINE;

DRUG APPROVAL; DRUG DESIGN; FEMALE; GUIDELINES AS TOPIC; HUMANS; LICENSURE; MALE; SOUTH AFRICA; TUBERCULOSIS VACCINES;

EID: 84893969202     PISSN: 14729792     EISSN: 1873281X     Source Type: Journal    
DOI: 10.1016/j.tube.2013.11.002     Document Type: Article

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