Gruber M - Search Results

1

Influenza immunization during pregnancy: US regulatory perspective.

Marshall V, Gruber M. Marshall V, et al. Among authors: gruber m. Am J Obstet Gynecol. 2012 Sep;207(3 Suppl):S57-62. doi: 10.1016/j.ajog.2012.06.075. Epub 2012 Jul 9. Am J Obstet Gynecol. 2012. PMID: 22920061 Review.

2

Regulatory considerations in the clinical development of vaccines indicated for use during pregnancy.

Roberts JN, Gruber MF. Roberts JN, et al. Vaccine. 2015 Feb 18;33(8):966-72. doi: 10.1016/j.vaccine.2014.12.068. Epub 2015 Jan 6. Vaccine. 2015. PMID: 25573034 Review.

3

Maternal immunization: US FDA regulatory considerations.

Gruber MF. Gruber MF. Vaccine. 2003 Jul 28;21(24):3487-91. doi: 10.1016/s0264-410x(03)00357-8. Vaccine. 2003. PMID: 12850366 Review.

4

The US FDA pregnancy lactation and labeling rule - Implications for maternal immunization.

Gruber MF. Gruber MF. Vaccine. 2015 Nov 25;33(47):6499-500. doi: 10.1016/j.vaccine.2015.05.107. Epub 2015 Aug 6. Vaccine. 2015. PMID: 26256527 Free article.

5

An overview of the regulation of influenza vaccines in the United States.

Weir JP, Gruber MF. Weir JP, et al. Influenza Other Respir Viruses. 2016 Sep;10(5):354-60. doi: 10.1111/irv.12383. Epub 2016 Mar 24. Influenza Other Respir Viruses. 2016. PMID: 27426005 Free PMC article.

6

Clinical evaluation of pertussis vaccines: US Food and Drug Administration regulatory considerations.

Farizo KM, Burns DL, Finn TM, Gruber MF, Pratt RD. Farizo KM, et al. Among authors: gruber mf. J Infect Dis. 2014 Apr 1;209 Suppl 1:S28-31. doi: 10.1093/infdis/jit532. J Infect Dis. 2014. PMID: 24626869 Review.

7

US FDA review and regulation of preventive vaccines for infectious disease indications: impact of the FDA Amendments Act 2007.

Gruber MF. Gruber MF. Expert Rev Vaccines. 2011 Jul;10(7):1011-9. doi: 10.1586/erv.11.52. Expert Rev Vaccines. 2011. PMID: 21806396 Review.

8

Global and national initiatives to facilitate studies of vaccines in pregnant women.

Gruber MF. Gruber MF. Clin Infect Dis. 2014 Dec 15;59 Suppl 7:S395-9. doi: 10.1093/cid/ciu707. Clin Infect Dis. 2014. PMID: 25425717 No abstract available.

9

Clinical Development Strategies and Considerations for Zika Vaccine Licensure.

Gruber MF, Farizo KM, Pratt RD, Fink DL, Finn TM, Krause PR, Borio LL, Marks PW. Gruber MF, et al. J Infect Dis. 2017 Dec 16;216(suppl_10):S964-S970. doi: 10.1093/infdis/jix433. J Infect Dis. 2017. PMID: 29267913 Free PMC article. Review.

10

Evaluating human trials: FDA's role.

Krause PR, Gruber MF. Krause PR, et al. Science. 2018 Jun 22;360(6395):1308. doi: 10.1126/science.aau0591. Epub 2018 Jun 21. Science. 2018. PMID: 29930128 No abstract available.

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