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An overview of Canadian and U.S. approaches to drug regulation and responses to postmarket adverse drug reactions.
J Diabetes Sci Technol. 2013 Mar 01; 7(2):313-20.JD

Abstract

Over the years, drug products, including those indicated for diabetes, have been withdrawn from the marketplace because of quality concerns and/or severe adverse drug reactions. While the drug regulatory process is designed to detect, among other things, adverse drug reactions before a drug receives marketing authorization, for various reasons, premarket detection of all potential adverse reactions associated with a drug may not be possible. As such, regulatory authorities must also react to and manage adverse reactions identified at the postmarket stage. In this article, we provide a general overview of drug regulation in Canada and the United States and consider an example of a drug indicated for the treatment of diabetes and how newly identified potential safety concerns were managed in the postmarket environment.

Authors+Show Affiliations

Fasken Martineau DuMoulin LLP, 333 Bay St., Suite 2400, Toronto, Ontario, Canada M5H 2T6. rcheung@fasken.comNo affiliation info available

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

23566987

Citation

Cheung, Richard Y., and Sarah H. Goodwin. "An Overview of Canadian and U.S. Approaches to Drug Regulation and Responses to Postmarket Adverse Drug Reactions." Journal of Diabetes Science and Technology, vol. 7, no. 2, 2013, pp. 313-20.
Cheung RY, Goodwin SH. An overview of Canadian and U.S. approaches to drug regulation and responses to postmarket adverse drug reactions. J Diabetes Sci Technol. 2013;7(2):313-20.
Cheung, R. Y., & Goodwin, S. H. (2013). An overview of Canadian and U.S. approaches to drug regulation and responses to postmarket adverse drug reactions. Journal of Diabetes Science and Technology, 7(2), 313-20.
Cheung RY, Goodwin SH. An Overview of Canadian and U.S. Approaches to Drug Regulation and Responses to Postmarket Adverse Drug Reactions. J Diabetes Sci Technol. 2013 Mar 1;7(2):313-20. PubMed PMID: 23566987.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An overview of Canadian and U.S. approaches to drug regulation and responses to postmarket adverse drug reactions. AU - Cheung,Richard Y, AU - Goodwin,Sarah H, Y1 - 2013/03/01/ PY - 2013/4/10/entrez PY - 2013/4/10/pubmed PY - 2013/12/16/medline SP - 313 EP - 20 JF - Journal of diabetes science and technology JO - J Diabetes Sci Technol VL - 7 IS - 2 N2 - Over the years, drug products, including those indicated for diabetes, have been withdrawn from the marketplace because of quality concerns and/or severe adverse drug reactions. While the drug regulatory process is designed to detect, among other things, adverse drug reactions before a drug receives marketing authorization, for various reasons, premarket detection of all potential adverse reactions associated with a drug may not be possible. As such, regulatory authorities must also react to and manage adverse reactions identified at the postmarket stage. In this article, we provide a general overview of drug regulation in Canada and the United States and consider an example of a drug indicated for the treatment of diabetes and how newly identified potential safety concerns were managed in the postmarket environment. SN - 1932-2968 UR - https://www.unboundmedicine.com/medline/citation/23566987/An_overview_of_Canadian_and_U_S__approaches_to_drug_regulation_and_responses_to_postmarket_adverse_drug_reactions_ L2 - http://journals.sagepub.com/doi/full/10.1177/193229681300700205?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -