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Articles (106)

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1-10 of 106 results for FDA-regulated research

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Select article: History of FDA Regulation of Clinical Research

Retricted access

Research article

First published 1988-4

History of FDA Regulation of Clinical Research

Richard F. Kingham

Therapeutic Innovation & Regulatory Science

Select article: Research Deviations in FDA-Regulated Clinical Trials

Retricted access

Research article

First published 2018-9

Research Deviations in FDA-Regulated Clinical Trials

Craig A. Garmendia, Katrina Epnere, Neera Bhansali

Therapeutic Innovation & Regulatory Science

Select article: Research Misconduct in FDA-Regulated Clinical Trials

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Research article

First published 2018-9

Research Misconduct in FDA-Regulated Clinical Trials

Craig A. Garmendia, Neera Bhansali, Purnima Madhivanan

Therapeutic Innovation & Regulatory Science

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: Postapproval Research Requested by the FDA at the Time of NCE Approval,1970–1984

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Research article

First published 1987-7

Postapproval Research Requested by the FDA at the Time of NCE Approval,1970–1984

Nancy Mattison, Barbara W. Richard

Therapeutic Innovation & Regulatory Science

Select article: Regulatory Overview: Protection of Human Subjects — Irbs and Informed Consent

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Research article

First published 1987-4

Regulatory Overview: Protection of Human Subjects — Irbs and Informed Consent

Stuart L. Nightingale

Therapeutic Innovation & Regulatory Science

Select article: Understanding Food and Drug Administration Regulatory Requirements for an Investigational Device Exemption for Sponsor-Investigators

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Research article

First published 2012-10

Understanding Food and Drug Administration Regulatory Requirements for an Investigational Device Exemption for Sponsor-Investigators

M. E. Blair Holbein, Jelena Petrovic Berglund

Journal of Investigative Medicine

Select article: A reflection on paradigmatic tensions within the FDA advisory committee for MDMA-assisted therapy

Open access

Research article

First published 2025-4

A reflection on paradigmatic tensions within the FDA advisory committee for MDMA-assisted therapy

Leor Roseman

Journal of Psychopharmacology

Select article: Regulatory Requirements and Informed Consent

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Other

First published 2008-7

Regulatory Requirements and Informed Consent

Michael R. Hamrell

Therapeutic Innovation & Regulatory Science

Select article: Spin your science into gold: direct to consumer marketing within social media platforms

Free access

Research article

First published 2012-3

Spin your science into gold: direct to consumer marketing within social media platforms

David Egilman, Nicholas M. Druar

WORK: A Journal of Prevention,Assessment & Rehabilitation

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