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Articles (44)

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1-10 of 44 results for CDER

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

Retricted access

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

Select article: FDA/CDER/OND Experience With New Approach Methodologies (NAMs)

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Editorial

First published 2026-4

FDA/CDER/OND Experience With New Approach Methodologies (NAMs)

Jia Yao, Jackye Peretz, Ilona Bebenek [...]

International Journal of Toxicology

Select article: CDER Photosafety Guidance for Industry

Free access

Research article

First published 2004-2

CDER Photosafety Guidance for Industry

Abigail C. Jacobs, Paul C. Brown, Conrad Chen [...]

Toxicologic Pathology

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

Retricted access

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: The Regulation of Biological Products and the CBER-CDER Intercenter Agreements

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Research article

First published 1993-7

The Regulation of Biological Products and the CBER-CDER Intercenter Agreements

Michael E. Margolies

Therapeutic Innovation & Regulatory Science

Select article: The CDER Labeling and Nomenclature Committee: Structure,Function,and Process

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Research article

First published 1997-1

The CDER Labeling and Nomenclature Committee: Structure,Function,and Process

Daniel L. Boring

Therapeutic Innovation & Regulatory Science

Select article: CDER/FDA Formats for Submission of Animal Carcinogenicity Study Data *

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Other

First published 1998-1

CDER/FDA Formats for Submission of Animal Carcinogenicity Study Data *

Karl K. Lin

Therapeutic Innovation & Regulatory Science

Select article: CDER Experience With Juvenile Animal Studies for CNS Drugs

Free access

Research article

First published 2019-3

CDER Experience With Juvenile Animal Studies for CNS Drugs

J. Edward Fisher, Arippa Ravindran, Ikram Elayan

International Journal of Toxicology

Select article: Richard Pazdur,Director,Oncology Drug Products,CDER,FDA

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Research article

First published 2004-4

Richard Pazdur,Director,Oncology Drug Products,CDER,FDA

Journal of Investigative Medicine

Select article: Press Release: American Pharmaceutical Association FDA-CDER Stakeholder Meeting

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Research article

First published 1998-10

Press Release: American Pharmaceutical Association FDA-CDER Stakeholder Meeting

John A. Gans

Journal of Pharmacy Practice

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