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Pediatric post-marketing safety systems in North America: assessment of the current status.

Author: BonnelRenan, CopeJudith U, DeCelleMary, McMahonAnn W, MurphyMary Dianne, SmithPhillip Brian, SwankKimberley, TestoniDaniela, WhartonGerold T, WuEileen

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Overview

The Food and Drug Administration has identified several post-marketing safety systems for pediatric drugs. These systems should include enough clinical and epidemiological detail to draw regulatory, public health, and clinical conclusions.
Paper Details　
Original Abstract of the Article :
It is critical to have pediatric post-marketing safety systems that contain enough clinical and epidemiological detail to draw regulatory, public health, and clinical conclusions. The pediatric safety surveillance workshop (PSSW), coordinated by the Food and Drug Administration (FDA), identified the...See full text at original site
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引用元：
https://doi.org/10.1002/pds.3813

データ提供：米国国立医学図書館（NLM）

Pediatric Post-Marketing Safety Systems: A Vital Tool for Protecting Children

The safety of medications for children is a paramount concern for healthcare professionals and regulatory agencies. This study examined the current state of pediatric post-marketing safety systems in North America, highlighting the need for robust systems that collect comprehensive data on the safety of medications in children.

Safeguarding the Future: Pediatric Safety Surveillance

The study emphasizes the critical role of pediatric post-marketing safety systems in ensuring the safe use of medications in children. The authors discuss the need for systems that collect detailed clinical and epidemiological data to enable effective monitoring and regulatory decision-making.

A Desert of Data: Protecting Our Youngest

Just as a camel needs to navigate the desert with care, ensuring the safety of medications for children requires a meticulous approach. This study highlights the importance of robust pediatric post-marketing safety systems to protect the health and well-being of our youngest population. Remember, safeguarding the future of children depends on ensuring the safety of the medications they use.

Dr.Camel's Conclusion

This study underscores the vital importance of pediatric post-marketing safety systems in protecting the health of children. The need for comprehensive and detailed data collection is essential for monitoring the safety of medications in this vulnerable population. Remember, ensuring the safety of medications for children is a shared responsibility, and continued efforts to improve post-marketing surveillance systems are essential for safeguarding their well-being.

Date :
  1. Date Completed 2016-05-04
  2. Date Revised 2015-08-05
Further Info :

Pubmed ID

26098297

DOI: Digital Object Identifier

10.1002/pds.3813

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Languages

English

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