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Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific Workshop, October 28-29, 2014.

Publication ,  Journal Article
Offringa, M; Davis, JM; Turner, MA; Ward, R; Bax, R; Maldonado, S; Sinha, V; McCune, SK; Zajicek, A; Benjamin, DK; Bucci-Rechtweg, C; Nelson, RM
Published in: Ther Innov Regul Sci
September 2015

The First Annual Neonatal Scientific Workshop focused on the needs of the neonate by addressing the basic question: what information is required to inform decision making both at the regulatory level and at the bedside? Priority therapeutic areas include neonatal lung, brain, and gastrointestinal injury, retinopathy of prematurity, sepsis, and neonatal abstinence syndrome. Scientific progress in these therapeutic areas, regulatory standards, and the acceptable design and conduct of clinical trials must be aligned. This report will review potential approaches to enhancing neonatal drug development.

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Published In

Ther Innov Regul Sci

DOI

EISSN

2168-4804

Publication Date

September 2015

Volume

49

Issue

5

Start / End Page

623 / 631

Location

Switzerland

Related Subject Headings

  • Statistics & Probability
  • 4905 Statistics
  • 3214 Pharmacology and pharmaceutical sciences
  • 1117 Public Health and Health Services
  • 0104 Statistics
 

Citation

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Offringa, M., Davis, J. M., Turner, M. A., Ward, R., Bax, R., Maldonado, S., … Nelson, R. M. (2015). Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific Workshop, October 28-29, 2014. Ther Innov Regul Sci, 49(5), 623–631. https://doi.org/10.1177/2168479015597730
Offringa, Martin, Jonathan M. Davis, Mark A. Turner, Robert Ward, Ralph Bax, Sam Maldonado, Vikram Sinha, et al. “Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific Workshop, October 28-29, 2014.Ther Innov Regul Sci 49, no. 5 (September 2015): 623–31. https://doi.org/10.1177/2168479015597730.
Offringa, Martin, et al. “Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific Workshop, October 28-29, 2014.Ther Innov Regul Sci, vol. 49, no. 5, Sept. 2015, pp. 623–31. Pubmed, doi:10.1177/2168479015597730.
Offringa M, Davis JM, Turner MA, Ward R, Bax R, Maldonado S, Sinha V, McCune SK, Zajicek A, Benjamin DK, Bucci-Rechtweg C, Nelson RM. Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific Workshop, October 28-29, 2014. Ther Innov Regul Sci. 2015 Sep;49(5):623–631.
Journal cover image

Published In

Ther Innov Regul Sci

DOI

EISSN

2168-4804

Publication Date

September 2015

Volume

49

Issue

5

Start / End Page

623 / 631

Location

Switzerland

Related Subject Headings

  • Statistics & Probability
  • 4905 Statistics
  • 3214 Pharmacology and pharmaceutical sciences
  • 1117 Public Health and Health Services
  • 0104 Statistics