title: An overview of Canadian and U.S. approaches to drug regulation and responses to postmarket adverse drug reactions.
abstract: Over the years, drug products, including those indicated for diabetes, have been withdrawn from the marketplace because of quality concerns and/or severe adverse drug reactions.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.affiliation: Fasken Martineau DuMoulin LLP, 333 Bay St., Suite 2400, Toronto, Ontario, Canada M5H 2T6. rcheung@fasken.com
authors.forename: Richard Y
authors.initials: RY
authors.lastname: Cheung
authors.forename: Sarah H
authors.initials: SH
authors.lastname: Goodwin
mesh_terms: D002170:Canada; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence / Q000379:methods* / Q000458:organization & administration / Q000639:trends; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D061214:Patient Safety / Q000331:legislation & jurisprudence; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000639:trends; D000077154:Rosiglitazone; D045162:Thiazolidinediones / Q000627:therapeutic use; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000458:organization & administration
chemical_list: D007004:Hypoglycemic Agents; D045162:Thiazolidinediones; D000077154:Rosiglitazone