Guidance for pediatric use in prescription information for novel medicinal products in the EU and the US

• Helle Christiansen ,

  Roles Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Project administration, Resources, Software, Visualization, Writing – original draft

  * E-mail: hchristiansen@sund.ku.dk

  Affiliation Department of Pharmacy, Faculty of Health and Medical Sciences, Copenhagen Centre for Regulatory Science, University of Copenhagen, Copenhagen, Denmark

  https://orcid.org/0000-0003-4893-4622

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• Marie L. De Bruin,

  Roles Conceptualization, Funding acquisition, Methodology, Supervision, Validation, Writing – review & editing

  Affiliations Department of Pharmacy, Faculty of Health and Medical Sciences, Copenhagen Centre for Regulatory Science, University of Copenhagen, Copenhagen, Denmark, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands

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• Sven Frokjaer,

  Roles Conceptualization, Methodology, Supervision, Writing – review & editing

  Affiliation Department of Pharmacy, Faculty of Health and Medical Sciences, Copenhagen Centre for Regulatory Science, University of Copenhagen, Copenhagen, Denmark

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• Christine E. Hallgreen

  Roles Conceptualization, Funding acquisition, Investigation, Methodology, Supervision, Validation, Visualization, Writing – original draft, Writing – review & editing

  Affiliation Department of Pharmacy, Faculty of Health and Medical Sciences, Copenhagen Centre for Regulatory Science, University of Copenhagen, Copenhagen, Denmark

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