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Sponsor Initiated Requests to Delay Pediatric Postmarketing Studies.

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Title: Sponsor Initiated Requests to Delay Pediatric Postmarketing Studies.
Authors: Abdel-Rahman SM; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA. susan.abdel-rahman@fda.hhs.gov.; US Food and Drug Administration, 550 W Jackson Blvd, Fl 8, Chicago, IL, 60661, USA. susan.abdel-rahman@fda.hhs.gov., Gong Y; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Choi C; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Guity N; Division of Pediatrics and Maternal Health, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Burckart GJ; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Yao L; Division of Pediatrics and Maternal Health, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Source: Pharmaceutical medicine [Pharmaceut Med] 2026 May; Vol. 40 (3), pp. 225-233. Date of Electronic Publication: 2026 May 10.
Publication Type: Journal Article
Journal Info: Publisher: Adis, Springer International Country of Publication: New Zealand NLM ID: 101471195 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1179-1993 (Electronic) Linking ISSN: 11782595 NLM ISO Abbreviation: Pharmaceut Med Subsets: MEDLINE
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  Data: Sponsor Initiated Requests to Delay Pediatric Postmarketing Studies.
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  Data: <searchLink fieldCode="AU" term="%22Abdel-Rahman+SM%22">Abdel-Rahman SM</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA. susan.abdel-rahman@fda.hhs.gov.; US Food and Drug Administration, 550 W Jackson Blvd, Fl 8, Chicago, IL, 60661, USA. susan.abdel-rahman@fda.hhs.gov.<br /><searchLink fieldCode="AU" term="%22Gong+Y%22">Gong Y</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Choi+C%22">Choi C</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Guity+N%22">Guity N</searchLink>; Division of Pediatrics and Maternal Health, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Burckart+GJ%22">Burckart GJ</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Yao+L%22">Yao L</searchLink>; Division of Pediatrics and Maternal Health, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
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  Data: <searchLink fieldCode="JN" term="%22101471195%22">Pharmaceutical medicine</searchLink> [Pharmaceut Med] 2026 May; Vol. 40 (3), pp. 225-233. <i>Date of Electronic Publication: </i>2026 May 10.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Adis%2C+Springer+International%22">Adis, Springer International </searchLink><i>Country of Publication: </i>New Zealand <i>NLM ID: </i>101471195 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1179-1993 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2211782595%22">11782595 </searchLink><i>NLM ISO Abbreviation: </i>Pharmaceut Med <i>Subsets: </i>MEDLINE
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        Value: 10.1007/s40290-026-00610-4
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        Text: English
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      – TitleFull: Sponsor Initiated Requests to Delay Pediatric Postmarketing Studies.
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              Text: 2026 May
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              Y: 2026
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              Value: 1179-1993
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              Value: 40
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