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Retricted access

Other

First published 1999-1

Submitting Biologics Applications to the Center for Biologics Evaluation and Research Electronically

Mary A. Buesing, Edward McSweegan

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 2003-7

Jesse Goodman Named Director of Food and Drug Administration's Center for Biologics Evaluation and Research

Jesse Goodman

Journal of Investigative Medicine

Open access

Review article

First published 2018-12-20

Regenerative Medicine Therapies for Rare Diseases

Larissa Lapteva, Ramjay Vatsan, Tejashri Purohit-Sheth

Translational Science of Rare Diseases

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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

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Research article

First published 1998-1

A Primer on CBER'S Regulatory Review Structure and Process

Suzanne M. Sensabaugh

Therapeutic Innovation & Regulatory Science

Free access

Other

First published 1996-09

Food and Drug Administration Workshop on Indirect Mechanisms of Carcinogenesis

Lionel A. Poirier

Toxicologic Pathology

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Research article

First published 2007-07

Developmental regression and autism reported to the Vaccine Adverse Event Reporting System

Emily Jane Woo, Robert Ball, Rebecca Landa [...]

Autism

Free access

Research article

First published 1994-3

Safety Assessment Programs for U.S. Regulatory Agencies: A Perspective of Requirements and Compliance

Raymond A. Bendele

Toxicologic Pathology

Retricted access

Research article

First published 1996-5

Wellness Theory: A Discussion and Application to Clients with Disabilities

Gwyn C. Jones, Allie C. Kilpatrick

Families in Society: The Journal of Contemporary Social Services

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Research article

First published 2018-2

Family-Centered Care and Positive Developmental Outcomes for Youth With Special Health Care Needs: Variations Across Family Structures

Luke T. Russell, Jonathon J. Beckmeyer, Chang Su-Russell

Journal of Family Nursing

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