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A Review of Trials for Unsuccessful Pediatric Drug Development Programs Submitted to the US Food and Drug Administration 2015-2022.

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Title: A Review of Trials for Unsuccessful Pediatric Drug Development Programs Submitted to the US Food and Drug Administration 2015-2022.
Authors: Samuels S; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 51 Rm 3184, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA., Seaton M; Office of Study Integrity and Surveillance, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Abdel-Rahman SM; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 51 Rm 3184, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA., Burckart GJ; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 51 Rm 3184, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA. Gilbert.Burckart@fda.hhs.gov.
Source: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2026 Jan; Vol. 60 (1), pp. 153-160. Date of Electronic Publication: 2025 Oct 04.
Publication Type: Journal Article; Review
Journal Info: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: A Review of Trials for Unsuccessful Pediatric Drug Development Programs Submitted to the US Food and Drug Administration 2015-2022.
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  Data: <searchLink fieldCode="AU" term="%22Samuels+S%22">Samuels S</searchLink>; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 51 Rm 3184, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Seaton+M%22">Seaton M</searchLink>; Office of Study Integrity and Surveillance, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Abdel-Rahman+SM%22">Abdel-Rahman SM</searchLink>; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 51 Rm 3184, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Burckart+GJ%22">Burckart GJ</searchLink>; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 51 Rm 3184, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA. Gilbert.Burckart@fda.hhs.gov.
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  Data: <searchLink fieldCode="JN" term="%22101597411%22">Therapeutic innovation & regulatory science</searchLink> [Ther Innov Regul Sci] 2026 Jan; Vol. 60 (1), pp. 153-160. <i>Date of Electronic Publication: </i>2025 Oct 04.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Springer+International+Publishing%22">Springer International Publishing </searchLink><i>Country of Publication: </i>Switzerland <i>NLM ID: </i>101597411 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>2168-4804 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2221684790%22">21684790 </searchLink><i>NLM ISO Abbreviation: </i>Ther Innov Regul Sci <i>Subsets: </i>MEDLINE
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        Value: 10.1007/s43441-025-00864-1
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        Text: English
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              Text: 2026 Jan
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