The widespread availability of drugs for personalized medicine has been an aspiration since before the human genome was sequenced. Recently, there is renewed interest; personalized medicine is much...read more

This Article describes and evaluates two elements of the FDA’s recent operations implicating information transparency: the Transparency Initiative and a reduction in the agency’s FOIA b...read more

The Supreme Court’s decisions in Twombly and Iqbal ushered in a new federal pleading standard, requiring plaintiffs to state a “plausible” claim to relief before they can access d...read more

Georgetown University Law Center: Reflections on Current Food and Drug Law Issues For this inaugural issue of the FDLI–Georgetown University partnership we feature Georgetown University Law...read more

Internet crowdfunding, a new and increasingly popular method of raising capital to develop products and businesses, has recently come into conflict with the Food and Drug Administration’s (FD...read more

Mobile applications provide limitless possibilities for the future of medical care. Yet these changes have also created concerns about patient safety. Under the Federal Food, Drug, and Cosmetic Act...read more

The statute and regulations administered by the Food and Drug Administration (“FDA”) do not explicitly prohibit the promotion of drugs and medical devices for unapproved uses, yet the g...read more

Ensuring Medical Device Effectiveness and Safety: A Cross — National Comparison of Approaches to Regulation, 69 Food and Drug Law Journal, 1-24 (2014)

Posted on January 2014 by Daniel B. Kramer, M.D., Yongtian T. Tan, Chiaki Sato, Ph.D., LL.M. and Aaron S. Kesselheim, M.D., J.D., M.P.H.

Regulatory bodies weighing market approval for novel medical devices must balance the benefits and potential hazards carefully. We performed a legal and policy review of appraoches in the US, EU, J...read more

The rapidly evolving realm of modern commerce strains traditional regulatory paradigms. This paper traces the historical evolution of FDA crisis-response regulation and provides examples of ways in...read more

FDA warning letters are considered non-final agency actions and thus are not subject to judicial review under the Administrative Procedure Act (APA). The Supreme Court’s analysis in Sackett v...read more