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Academia and industry: lessons from the unfortunate events in Toronto.

https://arctichealth.org/en/permalink/ahliterature201078
Source
Lancet. 1999 Mar 6;353(9155):771-2
Publication Type
Article
Date
Mar-6-1999
Author
D G Nathan
D J Weatherall
Author Affiliation
Dana Farber Institute of Cancer Research, Boston, MA, USA.
Source
Lancet. 1999 Mar 6;353(9155):771-2
Date
Mar-6-1999
Language
English
Publication Type
Article
Keywords
Academic Medical Centers - legislation & jurisprudence - trends
Clinical Trials as Topic - legislation & jurisprudence
Drug Industry - legislation & jurisprudence - trends
Humans
Iron Chelating Agents - therapeutic use
Ontario
Pyridones - therapeutic use
Thalassemia - drug therapy
Notes
Comment In: Lancet. 1999 May 29;353(9167):188810359449
PubMed ID
10459956 View in PubMed
Less detail
Source
Can Nurse. 1996 Sep;92(8):60, 59
Publication Type
Article
Date
Sep-1996

A call for the regulation of prescription data mining.

https://arctichealth.org/en/permalink/ahliterature196618
Source
CMAJ. 2000 Oct 31;163(9):1146-8
Publication Type
Article
Date
Oct-31-2000
Author
D E Zoutman
B D Ford
A R Bassili
Author Affiliation
Department of Pathology, Queen's University, Kingston, Ont. zoutman@cliff.path.queensu.ca
Source
CMAJ. 2000 Oct 31;163(9):1146-8
Date
Oct-31-2000
Language
English
Publication Type
Article
Keywords
Canada
Data Collection - legislation & jurisprudence
Drug Industry - legislation & jurisprudence
Drug Prescriptions - statistics & numerical data
Ethics, Medical
Humans
Pharmacies - legislation & jurisprudence
Notes
Cites: CMAJ. 1996 Jun 1;154(11):1747-98646667
Cites: CMAJ. 1997 Feb 1;156(3):424A-424D9033430
Comment In: CMAJ. 2001 May 15;164(10):1409; author reply 1409-1011387912
Comment In: CMAJ. 2001 May 15;164(10):1408; author reply 1409-1011387911
Comment In: CMAJ. 2001 May 15;164(10):1408; author reply 1409-1011387910
Comment In: CMAJ. 2001 May 15;164(10):1408-9; author reply 1409-1011387909
PubMed ID
11079059 View in PubMed
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Canadian court upholds Glaxo's patent on AZT.

https://arctichealth.org/en/permalink/ahliterature191593
Source
Can HIV AIDS Policy Law Rev. 2001;6(1-2):53-7
Publication Type
Article
Date
2001
Author
R. Elliott
Source
Can HIV AIDS Policy Law Rev. 2001;6(1-2):53-7
Date
2001
Language
English
French
Publication Type
Article
Keywords
Canada
Drug Industry - legislation & jurisprudence
Drugs, Generic
HIV Infections - drug therapy
Humans
Patents as Topic - legislation & jurisprudence
Reverse Transcriptase Inhibitors - therapeutic use
Zidovudine - therapeutic use
Abstract
In October 2000, the Federal Court of Appeal issued the latest ruling in the ongoing dispute over the validity of Glaxo's Canadian patent for AZT, upholding Glaxo's patent but narrowing the scope of the claims it could validly make. The decision is now on appeal to the Supreme Court of Canada.
PubMed ID
11837029 View in PubMed
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Canadian marketing codes: how well are they controlling pharmaceutical promotion?

https://arctichealth.org/en/permalink/ahliterature219217
Source
Int J Health Serv. 1994;24(1):91-104
Publication Type
Article
Date
1994
Author
J. Lexchin
Source
Int J Health Serv. 1994;24(1):91-104
Date
1994
Language
English
Publication Type
Article
Keywords
Advertising as Topic - legislation & jurisprudence
Canada
Drug Industry - legislation & jurisprudence
Drug Information Services - legislation & jurisprudence
Drug Prescriptions
Ethics, Pharmacy
Humans
Abstract
Pharmaceutical promotion in Canada is controlled by two codes: a voluntary one developed by the Pharmaceutical Advertising Advisory Board dealing mostly with printed promotional material, and one from the Pharmaceutical Manufacturers Association of Canada covering other forms of promotion. This article looks at enforcement of the provisions of these codes and at areas in which they are deficient. One of the major weaknesses in both codes is their lack of effective sanctions for companies that violate their provisions. Strong codes are necessary because many physicians rely heavily on promotional material for their source of prescribing information. However, voluntary codes or codes developed by the industry are inherently weak and lack effective enforcement mechanisms. Although the U.S. Food and Drug Administration is currently very active in curtailing promotional excesses, government control is not the solution since regulatory action will depend on the ideological position of the head of the regulatory body and/or the party in power. An independent body backed by legislative authority is preferable.
PubMed ID
8150569 View in PubMed
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The Canadian Natural Health Products (NHP) regulations: industry perceptions and compliance factors.

https://arctichealth.org/en/permalink/ahliterature169089
Source
BMC Health Serv Res. 2006;6:63
Publication Type
Article
Date
2006
Author
Hina Laeeque
Heather Boon
Natasha Kachan
Jillian Clare Cohen
Joseph D'Cruz
Author Affiliation
Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Canada. hina.laeeque@utoronto.ca
Source
BMC Health Serv Res. 2006;6:63
Date
2006
Language
English
Publication Type
Article
Keywords
Canada
Consumer Product Safety - legislation & jurisprudence
Dietary Supplements - standards
Drug Industry - legislation & jurisprudence
Government Regulation
Guideline Adherence - statistics & numerical data
Health Care Surveys
Humans
Interviews as Topic
Licensure - legislation & jurisprudence
Minerals - standards
Product Line Management - legislation & jurisprudence - standards
Questionnaires
Vitamins - standards
Abstract
The use of natural health products, such as vitamins, minerals, and herbs, by Canadians has been increasing with time. As a result of consumer concern about the quality of these products, the Canadian Department of Health created the Natural Health Products (NHP) Regulations. The new Canadian regulations raise questions about whether and how the NHP industry will be able to comply and what impact they will have on market structure. The objectives of this study were to explore who in the interview sample is complying with Canada's new NHP Regulations (i.e., submitted product licensing applications on time); and explore the factors that affect regulatory compliance.
Twenty key informant interviews were conducted with employees of the NHP industry. The structured interviews focused on the level of satisfaction with the Regulations and perceptions of compliance and non-compliance. Interviews were tape recorded and then transcribed verbatim. Data were independently coded, using qualitative content analysis. Team meetings were held after every three to four interviews to discuss emerging themes.
The major finding of this study is that most (17 out of 20) companies interviewed were beginning to comply with the new regulatory regime. The factors that contribute to likelihood of regulatory compliance were: perceptions and knowledge of the regulations and business size.
The Canadian case can be instructive for other countries seeking to implement regulatory standards for natural health products. An unintended consequence of the Canadian NHP regulations may be the exit of smaller firms, leading to industry consolidation.
Notes
Cites: JAMA. 1998 Nov 11;280(18):1569-759820257
PubMed ID
16734916 View in PubMed
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The Canadian perspective: trends in drug and medical device class actions in Canada.

https://arctichealth.org/en/permalink/ahliterature167389
Source
Food Drug Law J. 2006;61(3):569-76
Publication Type
Article
Date
2006

Challenges in natural health product research: The importance of standardization.

https://arctichealth.org/en/permalink/ahliterature156309
Source
Proc West Pharmacol Soc. 2007;50:24-30
Publication Type
Article
Date
2007
Author
Jacqueline J Shan
Kathryn Rodgers
Chien-Tsai Lai
Sharla K Sutherland
Author Affiliation
CV Technologies Inc., Edmonton Research Park, Edmonton, Alberta, Canada. drshan@cvtechnologies.com
Source
Proc West Pharmacol Soc. 2007;50:24-30
Date
2007
Language
English
Publication Type
Article
Keywords
Algorithms
Biological Products - standards
Canada
Drug Industry - legislation & jurisprudence - standards
Herbal Medicine - legislation & jurisprudence - standards
Humans
Panax - chemistry
Plant Extracts - standards
Randomized Controlled Trials as Topic
Abstract
Before there can be acceptance of natural health products (NHPs) or "phytomedicines" by the Western medical community, questions related to active ingredients, mechanisms of action, toxicology, and drug interactions will need to be satisfactorily addressed. Since NHPs are generally manufactured from highly variable raw materials, identifying the therapeutically active ingredients can be challenging. Standardization according to all known bioactive components is critical to ensure consistent pharmacological and clinical results. CV Technologies, Inc. has made great strides in resolving these challenges through the patented technology, ChemBioPrint. During early ChemBioPrint product development, the optimal active components of a natural extract are identified and characterized chemically (chemical fingerprinting) and pharmacologically through a variety of activity assays (biological fingerprinting). Subsequent manufacturing steps ensure each batch is standardized accordingly and has consistent composition and efficacy. Case studies will be presented on two commercially available ChemBioPrint products: COLD-fX (an immune-modulator) and REMEMBER-fX (a neuro-modulator). Unique and important structure-function relationships exist between the major classes of bioactive molecules from the shared source material of these two products, Panax quinquefolius. Through numerous published and ongoing clinical trials and pharmacological studies, these ChemBioPrint products have been shown to be consistent, safe and effective. The future directions of NHP research will be discussed, including the requirements for accurate reporting of study results related to ingredient and standardization descriptions.
PubMed ID
18605225 View in PubMed
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53 records – page 1 of 6.