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Research article

First published 2019-11

The Meanings of “Pediatric Drug Development”

Klaus Rose, Jane M Grant-Kels

Therapeutic Innovation & Regulatory Science

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Other

First published 1998-1

Labeling of Drug and Biologic Products for Pediatric Use

Emily Shacter, Patricia L. DeSantis

Therapeutic Innovation & Regulatory Science

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Review article

First published 2022-3

US Food and Drug Administration Facilitated Pediatric Approval Programs: Application to Pediatric Neurological Disorders

Emily Da Cruz, Faraan Rahim, Monica Lemmon [...]

Journal of Child Neurology

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Other

First published 2015-3

Adverse Event Detection and Labeling in Pediatric Drug Development

Jeremiah D. Momper, Yang Chang, Matthew Jackson [...]

Therapeutic Innovation & Regulatory Science

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Other

First published 1999-4

Pediatric Drug Formulations: A Rate-Limiting Step

Milap C. Nahata

Therapeutic Innovation & Regulatory Science

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Research article

First published 1996-10

FDA Center for Drug Evaluation and Research (CDER) Pediatric Plan and New Regulations

Rosemary Roberts, Samuel Maldonado

Therapeutic Innovation & Regulatory Science

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Other

First published 2006-4

Safer,Better,More Appropriate: Clinical Trial Design for Pediatric Drug Labels

Susan K. McCune, Lisa L. Mathis, David M. Cocchetto [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2016-9

Nonclinical Safety Considerations for the Development of Pediatric-First Drugs

G. Schmitt, J. Ridings, L. De Schaepdrijver [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2019-9

Role of Patients and Parents in Pediatric Drug Development

Vivian W. L. Tsang, Leanne West, Christine Woods [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2015-12

Adverse Drug Reactions in Pediatric Emergency Medicine

Domitille Darnis, Julien Mahé, Bénédicte Vrignaud [...]

Annals of Pharmacotherapy

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