Gruber MF - Search Results

1

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

Roberts JN, Gruber MF. Roberts JN, et al. Among authors: gruber mf. 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.

2

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.

3

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.

4

Meeting report: CEPI consultation on accelerating access to novel vaccines against emerging infectious diseases for pregnant and lactating women, London, 12-13 February 2020.

Voss G, Jacquet JM, Tornieporth N, Kampmann B, Karron R, Meulen AS, Chen R, Gruber M, Lurie N, Weller C, Cramer JP, Saville M, Darko M. Voss G, et al. Vaccine. 2021 Dec 17;39(51):7357-7362. doi: 10.1016/j.vaccine.2021.10.048. Epub 2021 Nov 17. Vaccine. 2021. PMID: 34799142 Free PMC article.

5

Influenza immunization during pregnancy: US regulatory perspective.

Marshall V, Gruber M. Marshall V, et al. 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.

6

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.

7

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.

8

Making more COVID-19 vaccines available to address global needs: Considerations and a framework for their evaluation.

Krause PR, Arora N, Dowling W, Muñoz-Fontela C, Funnell S, Gaspar R, Gruber MF, Hacker A, Henao-Restrepo AM, Plotkin S, Rees HV, Smith DK, Swaminathan S. Krause PR, et al. Among authors: gruber mf. Vaccine. 2022 Sep 22;40(40):5749-5751. doi: 10.1016/j.vaccine.2022.07.028. Epub 2022 Jul 26. Vaccine. 2022. PMID: 35941036 Free PMC article. No abstract available.

9

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.

10

Regulating vaccines at the FDA: development and licensure of Zika vaccines.

Gruber MF, Krause PR. Gruber MF, et al. Expert Rev Vaccines. 2017 Jun;16(6):525-527. doi: 10.1080/14760584.2017.1324304. Epub 2017 May 4. Expert Rev Vaccines. 2017. PMID: 28447498 No abstract available.

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