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The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise

Pharmacoepidemiology and drug safety, 2012-01, Vol.21 (S1), p.291-297

2012

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The US Food and Drug Administration's Sentinel Initiative: Expanding the horizons of medical product safety

Pharmacoepidemiology and drug safety, 2012-01, Vol.21 (S1), p.9-11

2012

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Karen Midthun

Nature reviews. Drug discovery, 2015-12, Vol.14 (12), p.814-814

2015

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Developing the Nation's Biosimilars Program

The New England journal of medicine, 2011-08, Vol.365 (5), p.385-388

2011

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Immunization-safety monitoring systems for the 2009 H1N1 monovalent influenza vaccination program

Pediatrics (Evanston), 2011-05, Vol.127 Suppl 1, p.S78

2011

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Evaluating the Safety of New Vaccines: Summary of a Workshop

American journal of public health (1971), 2005-05, Vol.95 (5), p.800-807

2005

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Rotavirus vaccines: an overview

Clinical microbiology reviews, 1996, Vol.9 (3), p.423-434

1996

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Global safety of vaccines: strengthening systems for monitoring, management and the role of GACVS

Expert review of vaccines, 2009-06, Vol.8 (6), p.705-716

2009

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Getting the Science Right and Doing the Right Science in Vaccine Safety

American journal of public health (1971), 2004-06, Vol.94 (6), p.914-917

2004

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Human milk mucin inhibits rotavirus replication and prevents experimental gastroenteritis

The Journal of clinical investigation, 1992-11, Vol.90 (5), p.1984-1991

1992

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Safety, Immunogenicity, and Protective Efficacy of One and Three Doses of the Tetravalent Rhesus Rotavirus Vaccine in Infants in Lima, Peru

The Journal of infectious diseases, 1996-08, Vol.174 (2), p.268-275

1996

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Safety and immunogenicity of live attenuated human–bovine (UK) reassortant rotavirus vaccines with VP7-specificity for serotypes 1, 2, 3 or 4 in adults, children and infants

Vaccine, 1999-06, Vol.17 (20), p.2715-2725

1999

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FDA senior management perspectives

Clinical trials (London, England), 2005-08, Vol.2 (4), p.373-378

2005

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Enhancing public confidence in vaccines through independent oversight of postlicensure vaccine safety. Commentary

American journal of public health (1971), 2004, Vol.94 (6), p.914-950

2004

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Genetic relatedness among human rotaviruses

Journal of medical virology, 1985-10, Vol.17 (2), p.135-143

1985

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Reactogenicity and antigenicity of rhesus rotavirus vaccine (MMU-18006) in newborn infants in Venezuela

The Pediatric infectious disease journal, 1988-11, Vol.7 (11), p.776-780

1988

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Independent Segregation of Two Antigenic Specificities (VP3 and VP7) Involved in Neutralization of Rotavirus Infectivity

Proceedings of the National Academy of Sciences - PNAS, 1985-12, Vol.82 (24), p.8701-8704

1985

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Safety and immunogenicity of a live attenuated hepatitis A virus vaccine in seronegative volunteers

The Journal of infectious diseases, 1991-04, Vol.163 (4), p.735

1991

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Selected regulatory and scientific topics for candidate vaccine development

The Journal of infectious diseases, 1996-09, Vol.174, p.S112

1996

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Selected Regulatory And Scientific Topics For Candidate Rotavirus Vaccine Development

The Journal of infectious diseases, 1996-09, Vol.174 (Supplement-1), p.S112-S117

1996

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Rotavirus: the major etiologic agent of severe infantile diarrhea may be controllable by a "Jennerian" approach to vaccination

The Journal of infectious diseases, 1986-05, Vol.153 (5), p.815

1986

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Safety and immunogenicity of live attenuated human–bovine (UK) reassortant rotavirus vaccines with VP7-specificity for serotypes 1, 2, 3 or 4 in adults, children and infants1This study was presented, in part, in a poster session at the Fifth Rotavirus Vaccine Workshop held on October 16–17, 1995, at the Centers for Disease Control and Prevention in Atlanta, GA. Informed consent was obtained from adult volunteers and the parents or guardians of pediatric participants. The guidelines for human exp

Vaccine, 1999-06, Vol.17 (20-21), p.2715-2725

1999

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Comparison of the amino acid sequences of the major neutralization protein of four human rotavirus serotypes

Virology (New York, N.Y.), 1987-11, Vol.161 (1), p.153-159

1987

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Chapter 73 - Regulation and testing of vaccines

Vaccines, 2008, p.1611-1627

Fifth Edition, 2008

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Safety and immunogenicity of human rotavirus vaccine strain M37 in adults, children, and infants

The Journal of infectious diseases, 1991-10, Vol.164 (4), p.792

1991

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The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise

The US Food and Drug Administration's Sentinel Initiative: Expanding the horizons of medical product safety

Karen Midthun

Developing the Nation's Biosimilars Program

Immunization-safety monitoring systems for the 2009 H1N1 monovalent influenza vaccination program

Evaluating the Safety of New Vaccines: Summary of a Workshop

Rotavirus vaccines: an overview

Global safety of vaccines: strengthening systems for monitoring, management and the role of GACVS

Getting the Science Right and Doing the Right Science in Vaccine Safety

Human milk mucin inhibits rotavirus replication and prevents experimental gastroenteritis

Safety, Immunogenicity, and Protective Efficacy of One and Three Doses of the Tetravalent Rhesus Rotavirus Vaccine in Infants in Lima, Peru

Safety and immunogenicity of live attenuated human–bovine (UK) reassortant rotavirus vaccines with VP7-specificity for serotypes 1, 2, 3 or 4 in adults, children and infants

FDA senior management perspectives

Enhancing public confidence in vaccines through independent oversight of postlicensure vaccine safety. Commentary

Genetic relatedness among human rotaviruses

Reactogenicity and antigenicity of rhesus rotavirus vaccine (MMU-18006) in newborn infants in Venezuela

Independent Segregation of Two Antigenic Specificities (VP3 and VP7) Involved in Neutralization of Rotavirus Infectivity

Safety and immunogenicity of a live attenuated hepatitis A virus vaccine in seronegative volunteers

Selected regulatory and scientific topics for candidate vaccine development

Selected Regulatory And Scientific Topics For Candidate Rotavirus Vaccine Development

Rotavirus: the major etiologic agent of severe infantile diarrhea may be controllable by a "Jennerian" approach to vaccination

Comparison of the amino acid sequences of the major neutralization protein of four human rotavirus serotypes

Chapter 73 - Regulation and testing of vaccines

Safety and immunogenicity of human rotavirus vaccine strain M37 in adults, children, and infants

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