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Articles (10)

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1-10 of 10 results for Pediatric Research Equity Act

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Select article: Suitability petitions and Pediatric Research Equity Act evaluation—Basic understanding and recent case studies

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Research article

First published 2013-9

Suitability petitions and Pediatric Research Equity Act evaluation—Basic understanding and recent case studies

Nirav Amitkumar Chokshi

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Select article: Guidance for Industry: How to Comply with the Pediatric Research Equity Act

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Research article

First published 2005-12

Guidance for Industry: How to Comply with the Pediatric Research Equity Act

Biotechnology Law Report

Select article: Drug labeling changes and pediatric hematology/oncology prescribing: Measuring the impact of U.S. legislation

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Research article

First published 2021-12

Drug labeling changes and pediatric hematology/oncology prescribing: Measuring the impact of U.S. legislation

Tyler J Benning, Nilay D Shah, Jonathan W Inselman [...]

Clinical Trials

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

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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

Select article: A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA From 2007-2013

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Research article

First published 2016-9

A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA From 2007-2013

Gunter F. Egger, Gerold T. Wharton, Suzanne Malli [...]

Therapeutic Innovation & Regulatory Science

Select article: Pediatric Medicine Development

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Research article

First published 2017-5

Pediatric Medicine Development

Dobromir Penkov, Paolo Tomasi, Irmgard Eichler [...]

Therapeutic Innovation & Regulatory Science

Select article: Impact of Regulatory Incentive Programs on the Future of Pediatric Drug Development

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Review article

First published 2019-9

Impact of Regulatory Incentive Programs on the Future of Pediatric Drug Development

Elizabeth Yen, Jonathan M. Davis, Christopher-Paul Milne

Therapeutic Innovation & Regulatory Science

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

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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

Select article: Neonatal Safety Information Reported to the FDA During Drug Development Studies

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Research article

First published 2018-1

Neonatal Safety Information Reported to the FDA During Drug Development Studies

Debbie Avant, Gerri Baer, Jason Moore [...]

Therapeutic Innovation & Regulatory Science

Select article: Improving Child Development Screening: Implications for Professional Practice and Patient Equity

Open access

Research article

First published 2022

Improving Child Development Screening: Implications for Professional Practice and Patient Equity

John Meurer, Robert Rohloff, Lisa Rein [...]

Journal of Primary Care & Community Health

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