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

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Bibliographic Details
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
Description
ISSN:2168-4804
DOI:10.1007/s43441-025-00864-1