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Halcion: An Independent Assessment of Safety and Efficacy Data (1997)
Institute of Medicine (IOM)

Citation Manager

. "Appendix E: Resources Reviewed by the Committee." Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press, 1997.

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Halcion: An Independent Assessment of Safety and Efficacy Data

Title

Contents

Source

Upjohn literature search

Literature search identifying later studies

Upjohn

Literature provided by Public Citizen

All cited references, including Kales (1996), A Reassessment of Triazolam and Conflicting Scientific Expertise in British and American Medicines Control

Public Citizen

International data

Canadian product monograph for Halcion

 

Canada

Evaluations of Medications for Insomnia in Canada (EMIC)

 

Upjohn

Medicines Control Agency letter

Letter from the Licensing Authority to Upjohn, 1992

Public Citizen

Report of the Committee on Proprietary Medicinal Products

 

Upjohn

Report of the Committee on the Safety of Medicines

 

Public Citizen

UK Panel Report

Report of the Panel of Persons Appointed

United Kingdom

VAMP Information

Information on the General Practice Research Database (previously known as the Value Added Medical Practice [VAMP] Database)

Upjohn

Premarketing clinical trial data (from the New Drug Application)

Preapproval reviews

 

FDA

Premarketing clinical trials

 

FDA

Report of the database remake

 

FDA

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