This study was undertaken to compare decisions about medicines innovation made by two Canadian organizations, the Therapeutic Products Directorate (TPD) and the Human Drug Advisory Panel (HDAP), with those made by similar organizations in other countries.

Although international medicines regulators adopt a common system to assess the safety and efficacy of new drugs, pre-market evaluation is recognized as incomplete given the much larger post-market experience to follow. Adverse drug reactions contribute to more than 100,000 deaths in the United...

Many health professional and regulatory groups have guidelines for identifying, disclosing and managing potential conflicts of interest (COI). The opinions of the Canadian public regarding what constitutes COI are unknown.

This paper offers an expository discussion of an approach to qualitative health research we call immanent critique. The central analytic move of immanent critique, as we have practiced it, is to explore how claims that are internal to authoritative discourse are experienced by those who have...

Research-based pharmaceutical companies maintain that there are important differences between themselves and their generic competitors. Prominent among them is an alleged greater ability to provide accurate and rapid responses to requests from physicians for information about drug products. This...

Objectives We aimed to systematically review and assess published estimates of the cost of developing new drugs.Methods We sought English language research articles containing original estimates of the cost of drug development that were published from 1980 to 2009, inclusive. We searched seven...