Halcion: An Independent Assessment of Safety and Efficacy Data (1997)
Chapter: Appendix E: Resources Reviewed by the Committee
E
Resources Reviewed by the Committee
|
Title |
Contents |
Source |
|
General background |
||
|
FDA Task Force Report |
|
FDA |
|
Public Citizen Petition |
The Public Citizen Petition to Remove Halcion from the Market |
Public Citizen |
|
Upjohn Response to Petition |
Upjohn's Response to the Public Citizen Petition |
FDA |
|
IOM Study on Sleep |
Basic Sleep Research, 1990 |
IOM |
|
IOM Study on Sleeping Pills |
Sleeping Pills, Insomnia, and Medical Practice, 1979 |
IOM |
|
Miscellaneous information provided by Upjohn |
Sales data, patent data, and information on generic compounds |
Upjohn |
|
Miscellaneous information provided by FDA |
Summary basis of approval, labeling information, information on generic compounds, and guidelines for the clinical evaluation of hypnotic drugs |
FDA |
|
Published literature |
||
|
IOM search |
Articles concerning Halcion |
IOM |
|
Literature on Halcion |
|
FDA |
|
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 |
|
Title |
Contents |
Source |
|
Upjohn summaries of non-pivotal clinical trials |
|
FDA |
|
Efficacy protocols |
Protocols for 20 studies with lower dosages reviewed for efficacy |
Upjohn |
|
Information from FDA Psychopharmacologic Drugs Advisory Committee meetings |
||
|
Transcript of the PDAC meetings: 1977, 1989, 1992 |
|
FDA |
|
FDA mailing to 1989 and 1992 PDACS |
FDA mailing to 1989 PDAC |
Upjohn |
|
Brochures with summary information prepared by Upjohn for the PDAC meetings, 1989 and 1992 |
Upjohn brochure prepared for the PDAC 1989 |
Upjohn |
|
Integrated Summaries of Safety and Efficacy |
||
|
Integrated safety study |
Integrated studies' of safety |
Upjohn |
|
Integrated efficacy study |
Integrated studies of effectiveness |
Upjohn |
|
Integrated dropout listings |
Integrated summary of safety dropout listings |
Upjohn |
|
Statistical reviews |
|
FDA |
|
Epidemiological reviews |
|
FDA |
|
Pharmocokinetic and pharmacodynamic data |
|
Upjohn |
|
Postmarketing surveillance data |
||
|
Annual Adverse Event Reports |
|
FDA |
|
Postmarketing protocols: 1994-1996 |
Protocols, M/2100/0235, M/2100/0366, and M/2100/0373 |
FDA |
|
Upjohn Annual Reports to FDA, 1990-1997 |
|
FDA |
|
Title |
Contents |
Source |
|
Spontaneous report data |
||
|
FDA memoranda |
FDA memoranda provided by Diane Wysowski |
FDA |
|
SRS data |
Data on the FDA Spontaneous Reporting System |
FDA |
|
Use, sales, and prescription data |
||
|
IMS statistics |
IMS statistics regarding reasons for prescriptions, high dose usage, and chronic usage |
Upjohn |
|
Use statistics |
Use statistics from IMS and health maintenance organization data regarding reasons for prescriptions, high dose usage, and chronic usage |
FDA |
|
Sales information |
Number of packages sold in the United States, 1982-1997 |
Upjohn |
