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1-10 of 154 results for FDA regulatory requirements

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Select article: Understanding FDA Regulatory Requirements for Investigational New Drug Applications for Sponsor-Investigators

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Research article

First published 2009-8

Understanding FDA Regulatory Requirements for Investigational New Drug Applications for Sponsor-Investigators

M. E. Blair Holbein

Journal of Investigative Medicine

Select article: Bringing Information on Evolving FDA Standards to Bear on Ongoing Drug Development Programs

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Other

First published 1999-7

Bringing Information on Evolving FDA Standards to Bear on Ongoing Drug Development Programs

Larry R. Versteegh, Lynne M. Tracey

Therapeutic Innovation & Regulatory Science

Select article: Bringing Information on Evolving FDA Standards to Bear on Ongoing Drug Development Programs

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Research article

First published 1995-10

Bringing Information on Evolving FDA Standards to Bear on Ongoing Drug Development Programs

Larry R. Versteegh

Therapeutic Innovation & Regulatory Science

Select article: FDA Approval of Antiretroviral Agents: An Evolving Paradigm

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Other

First published 1999-4

FDA Approval of Antiretroviral Agents: An Evolving Paradigm

Rachel E. Behrman

Therapeutic Innovation & Regulatory Science

Select article: Patient Experience Data in US Food and Drug Administration (FDA) Regulatory Decision Making:

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Research article

First published 2018-9

Patient Experience Data in US Food and Drug Administration (FDA) Regulatory Decision Making:

Carrie M. Kuehn

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: Food and Drug Administration Guidance: Supervisory Responsibilities of Investigators

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Review article

First published 2011-3

Food and Drug Administration Guidance: Supervisory Responsibilities of Investigators

Carl Anderson, Patti A. Young, Ann Berenbaum

Journal of Diabetes Science and Technology

Select article: GLP Compliance: A Rededication to Effective Quality Assurance

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Research article

First published 1986-07

GLP Compliance: A Rededication to Effective Quality Assurance

P. D. Lepore

International Journal of Toxicology

Select article: The Applicability of cGMP to Cord Blood Cell Banking

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Research article

First published 1996-04

The Applicability of cGMP to Cord Blood Cell Banking

Thomas F. Zuck

Stem Cells and Development

Select article: How the Critical Path Initiative Addresses CDER’s Regulatory Science Needs

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Research article

First published 2015-7

How the Critical Path Initiative Addresses CDER’s Regulatory Science Needs

Mark Geanacopoulos, Ruth Barratt

Therapeutic Innovation & Regulatory Science

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