EC, FDA and Health Canada

Vioxx: lessons for Health Canada and the FDA.

The Impact of US FDA and Health Canada Warnings Related to the Safety of High-dose Simvastatin

INTRODUCTION Between 2010 and 2012, the US Food and Drug Administration and Health Canada issued warnings to healthcare professionals emphasizing the increased risk of muscle problems with high-dose simvastatin. OBJECTIVE To measure the impact of the Health Canada safety warning regarding dose-dependent adverse effects of simvastatin on prescribing of low, medium, and high doses of simvastati...

Legalizing and Regulating Marijuana in Canada: Review of Potential Economic, Social, and Health Impacts

Notwithstanding a century of prohibition, marijuana is the most widely used illicit substance in Canada. Due to the growing public acceptance of recreational marijuana use and ineffectiveness of the existing control system in Canada, the issue surrounding legalizing this illicit drug has received considerable public and political attentions in recent years. Consequently, the newly elected Liber...

FDA regulation of mobile health technologies.

Medicine may stand at the cusp of a mobile transformation. Mobile health, or “mHealth,” is the use of portable devices such as smartphones and tablets for medical purposes, including diagnosis, treatment, or support of general health and well-being. Users can interface with mobile devices through software applications (“apps”) that typically gather input from interactive questionnaires, separat...

The FDA as a public health agency.

n engl j med 360;24 nejm.org june 11, 2009 2493 Act. The act sought to prevent the “manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors.” The office initially charged with this responsibility was the Bureau of Chemistry of the Department of Agriculture. Since that time, the bureau has grown into the Food and Drug Adm...