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Articles (25)

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1-10 of 25 results for CBER

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Select article: A Primer on CBER'S Regulatory Review Structure and Process

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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

Select article: CBER'S New Managed Review Process: A Managed and Integrated Regulatory Process Which is Continuous from Discovery to Post Marketing

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Research article

First published 1998-1

CBER'S New Managed Review Process: A Managed and Integrated Regulatory Process Which is Continuous from Discovery to Post Marketing

Suzanne M. Sensabaugh

Therapeutic Innovation & Regulatory Science

Select article: CBER’s Experience With Adaptive Design Clinical Trials

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Research article

First published 2016-3

CBER’s Experience With Adaptive Design Clinical Trials

Min Lin, Shiowjen Lee, Boguang Zhen [...]

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

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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

Select article: {BLR 2175}Cber - Fda - Vice-President Ai Gore

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News

First published 1996-01

{BLR 2175}Cber - Fda - Vice-President Ai Gore

Biotechnology Law Report

Select article: {BLR 2174}Ancillary Products - Cber - Culture Media - Fda - Gene Therapy

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News

First published 1996-01

{BLR 2174}Ancillary Products - Cber - Culture Media - Fda - Gene Therapy

Richard S. Schifreen, Cynthia A. Louth

Biotechnology Law Report

Select article: FDA Names Prasad CBER Director,Sparking Gene Therapy Review Concerns

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Research article

First published 2025-07

FDA Names Prasad CBER Director,Sparking Gene Therapy Review Concerns

Alex Philippidis

Human Gene Therapy

Select article: {BLR 1831}Advisory Committees - Bpac - Cber - Fda - Inds - Plas - Respigam - Winrho

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News

First published 1994-09

{BLR 1831}Advisory Committees - Bpac - Cber - Fda - Inds - Plas - Respigam - Winrho

Barbara A. Mcdowell

Biotechnology Law Report

Select article: Best Practices for the Advisory Committee Process for Products Regulated by CDER and CBER: A PhRMA White Paper

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First published 2008-1

Best Practices for the Advisory Committee Process for Products Regulated by CDER and CBER: A PhRMA White Paper

David M. Cocchetto, Thomas H. Hassall, Linda Carter [...]

Therapeutic Innovation & Regulatory Science

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