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 |
| Database: | MEDLINE Ultimate |
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