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Articles (187)

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1-10 of 187 results for Drug data file

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Select article: FDA's Adverse Drug Reaction Drug Dictionary and its Role in Post-Marketing Surveillance

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Research article

First published 1986-4

FDA's Adverse Drug Reaction Drug Dictionary and its Role in Post-Marketing Surveillance

Mary B. Forbes, Anastasia E. Perez, Alan Gelberg

Therapeutic Innovation & Regulatory Science

Select article: Online FDA Resources Versus Data on File: Minimizing Data on File in Standard Medical Response Letters

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First published 2012-5

Online FDA Resources Versus Data on File: Minimizing Data on File in Standard Medical Response Letters

Nancy Hwang, Angie Graham, Marbel Catolico

Therapeutic Innovation & Regulatory Science

Select article: The European Drug Master File

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Research article

First published 1993-10

The European Drug Master File

Giuseppe Battaglino

Therapeutic Innovation & Regulatory Science

Select article: Storage and Retrieval of Data from Drug Information Requests Using a Mumps-Based Information System

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Research article

First published 1986-1

Storage and Retrieval of Data from Drug Information Requests Using a Mumps-Based Information System

Marshall C. Tate, Lee Wanke, Philip Blume [...]

Therapeutic Innovation & Regulatory Science

Select article: Technological Developments with the FDA Adverse Drug Reaction File System

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First published 1991-1

Technological Developments with the FDA Adverse Drug Reaction File System

Alan Gelberg, George D. Armstrong, Michael W. Dreis [...]

Therapeutic Innovation & Regulatory Science

Select article: The Japanese drug master file

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Research article

First published 2011-10

The Japanese drug master file

Nirav Chokshi

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Select article: Munchausen Files in Scottish A&E Departments: A Review of Current Practice

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Research article

First published 2000-12

Munchausen Files in Scottish A&E Departments: A Review of Current Practice

L. C. Mcguire, P. T. Munro

Scottish Medical Journal

Select article: Ancillary Data Management

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Research article

First published 1988-1

Ancillary Data Management

Ted M. Kirsch, Maarja Hildebrand, Mirza Beg [...]

Therapeutic Innovation & Regulatory Science

Select article: Common Filing Deficiencies in Abbreviated New Drug Applications Containing Clinical Endpoint Studies

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Research article

First published 2019-1

Common Filing Deficiencies in Abbreviated New Drug Applications Containing Clinical Endpoint Studies

Lewis J. Fermaglich, Ru Chen, Carol Y. Kim [...]

Therapeutic Innovation & Regulatory Science

Select article: Electronic Reporting of Adverse Event Data to the Food and Drug Administration: The Experiences of Glaxo Wellcome and Zeneca as Participants in the Adverse Event Reporting System Pilot Project

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First published 1999-10

Electronic Reporting of Adverse Event Data to the Food and Drug Administration: The Experiences of Glaxo Wellcome and Zeneca as Participants in the Adverse Event Reporting System Pilot Project

Mark Blake, Vlasta Pinkston

Therapeutic Innovation & Regulatory Science

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