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Articles (66)

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1-10 of 66 results for FDA inspection

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Select article: Preparation for an FDA Sponsor/Monitor Inspection

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Research article

First published 1988-4

Preparation for an FDA Sponsor/Monitor Inspection

Allen F. Hirsch

Therapeutic Innovation & Regulatory Science

Select article: FDA'S Inspections of Clinical Investigators

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Research article

First published 1993-1

FDA'S Inspections of Clinical Investigators

Michael Bruckheimer

Therapeutic Innovation & Regulatory Science

Select article: FDA Inspection of Investigator Sites in Italy

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Research article

First published 1997-1

FDA Inspection of Investigator Sites in Italy

N. Brunetti, M. Roncolato, S. Zancan

Therapeutic Innovation & Regulatory Science

Select article: Preparing a Clinical Site for a Clinical Investigator Inspection by the FDA

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Other

First published 1999-1

Preparing a Clinical Site for a Clinical Investigator Inspection by the FDA

Charles F. Curran

Therapeutic Innovation & Regulatory Science

Select article: FDA Inspection of Clinical Research Sponsors and Investigators: Avoiding the Pitfalls

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Research article

First published 1988-4

FDA Inspection of Clinical Research Sponsors and Investigators: Avoiding the Pitfalls

C. Stephen Lawrence

Therapeutic Innovation & Regulatory Science

Select article: FDA Clinical Investigator Site Inspections: The Sponsor's Role

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Other

First published 1999-7

FDA Clinical Investigator Site Inspections: The Sponsor's Role

Richard D. Huddleston

Therapeutic Innovation & Regulatory Science

Select article: FDA'S Conduct,Review,and Evaluation of Inspections of Clinical Investigators

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Research article

First published 1987-4

FDA'S Conduct,Review,and Evaluation of Inspections of Clinical Investigators

Gurston Turner, Alan B. Lisook, Dana P. Delman

Therapeutic Innovation & Regulatory Science

Select article: Demonstrating the Effectiveness of the Quality Systems for An FDA Pre-NDA Approval Inspection

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Research article

First published 1994-10

Demonstrating the Effectiveness of the Quality Systems for An FDA Pre-NDA Approval Inspection

David Johnston

Therapeutic Innovation & Regulatory Science

Select article: The “N” in Pain is Silent: One Company's Approach to FDA Prenda Approval Inspections

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Other

First published 1998-7

The “N” in Pain is Silent: One Company's Approach to FDA Prenda Approval Inspections

Martin D. Hynes, Richard M. Justice, Jole O. Rodriguez [...]

Therapeutic Innovation & Regulatory Science

Select article: FDA Acceptance of Foreign Inspections

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Research article

First published 1993-10

FDA Acceptance of Foreign Inspections

Paul Vogel

Therapeutic Innovation & Regulatory Science

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