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Pharmaceutical Drugs Of Uncertain Value, Lifecycle Regulation At The Us Food And Drug Administration, And Institutional Incumbency, Matthew Herder

Articles, Book Chapters, & Popular Press

Policy Points

• The US Food and Drug Administration (FDA) has in recent years allowed onto the market several drugs with limited evidence of safety and effectiveness, provided that manufacturers agree to carry out additional studies while the drugs are in clinical use.
• Studies suggest that these postmarketing requirements (PMRs) frequently lack transparency, are subject to delays, and fail to answer the questions of greatest clinical importance. Yet, none of the literature speaks directly to the challenges that the FDA—as a regulatory institution—encounters in enforcing PMRs.
• Through a series of interviews with FDA leadership, this article analyzes and situates those challenges …

Ifit's Reusable Why Not Reuse It? The Reuse Of Single Use Medical Devices, Brian Wilson

Dalhousie Law Journal

The reprocessing and subsequent reuse of medical devices labelled by the manufacturer as 'single-use only' is a cost cutting strategy employed by many healthcare centres. However, attempting to extend the life of a device labelled as 'single-use only' raises a number of unique concerns surrounding the issue of legal liability specifically who should bear responsibility if someone suffers harm as a result of a reprocessed single-use device. Following an overview of the current regulatory environment, the potential tortious liability attaching to those who may be implicated in the reprocessing chain is discussed. Specifically, this paper examines the duty and standard …

Global Trecs: The Regulation Of International Trade In Cyberspace, J. Steele

Canadian Journal of Law and Technology

This paper provides an overview of trade-related aspects of electronic commerce, and examines three approaches for regulating international trade in cyber- space. A model which integrates these approaches is then proposed, emphasizing private standards of self-regula- tion within a broader public framework of minimal background standards. A summary of potential areas of conflict between competing regulatory approaches fol- lows, and the paper concludes that both the WTO and the OECD have important roles to play in the develop- ment of international consensus towards a harmonized framework for the regulation of global TRECs.