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Articles (23)

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1-10 of 23 results for Pediatric labeling regulation

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

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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

Select article: New Regulations for Pediatric Labeling of Prescription Drugs

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Editorial

First published 1996-9

New Regulations for Pediatric Labeling of Prescription Drugs

Milap C Nahata

Annals of Pharmacotherapy

Select article: Comment: Regulations for Pediatric Labeling of Prescription Drugs

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Research article

First published 1997-9

Comment: Regulations for Pediatric Labeling of Prescription Drugs

Clive Newman, David Hull, Milap C Nahata

Annals of Pharmacotherapy

Select article: Labeling of Drug and Biologic Products for Pediatric Use

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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

Select article: Needs and New Policies for Medicines for Children: The FDA,United States Incentives,and International Doings

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Other

First published 2000-1

Needs and New Policies for Medicines for Children: The FDA,United States Incentives,and International Doings

Paula Botstein

Therapeutic Innovation & Regulatory Science

Select article: Strategies for Pediatric Drug Evaluation: A View from the Trenches

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Research article

First published 1996-10

Strategies for Pediatric Drug Evaluation: A View from the Trenches

John T. Wilson

Therapeutic Innovation & Regulatory Science

Select article: Comparison of Unlicensed and Off-Label Use of Antipsychotics Prescribed to Child and Adolescent Psychiatric Outpatients for Treatment of Mental and Behavioral Disorders with Different Guidelines: The China Food and Drug Administration Versus the FDA

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Research article

First published 2018-04

Comparison of Unlicensed and Off-Label Use of Antipsychotics Prescribed to Child and Adolescent Psychiatric Outpatients for Treatment of Mental and Behavioral Disorders with Different Guidelines: The China Food and Drug Administration Versus the FDA

Xiuqing Zhu, Jinqing Hu, Bin Sun [...]

Journal of Child and Adolescent Psychopharmacology

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: Food and Drug Administration Requirements for Clinical Studies in Pediatric Patients

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Research article

First published 2015-9

Food and Drug Administration Requirements for Clinical Studies in Pediatric Patients

Edward Tabor

Therapeutic Innovation & Regulatory Science

Select article: Unique Aspects of Orphan Drug Safety

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Research article

First published 1994-4

Unique Aspects of Orphan Drug Safety

Marlene E. Haffner

Therapeutic Innovation & Regulatory Science

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