Law Commons^™

Planning For Excellence: Insights From An International Review Of Regulators’ Strategic Plans, Adam M. Finkel, Daniel E. Walters, Angus Corbett

Pace Environmental Law Review

What constitutes regulatory excellence? Answering this question is an indispensable first step for any public regulatory agency that is measuring, striving towards, and, ultimately, achieving excellence. One useful way to answer this question would be to draw on the broader literature on regulatory design, enforcement, and management. But, perhaps a more authentic way would be to look at how regulators themselves define excellence. However, we actually know remarkably little about how the regulatory officials who are immersed in the task of regulation conceive of their own success.

In this Article, we investigate regulators’ definitions of regulatory excellence by drawing on …

Mining For Children’S Data In Today’S Digital World, Damin Park

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Improving Post-Approval Risk Surveillance For Drugs: Active Post-Market Risk Identification, Matthew Gordon

Michigan Telecommunications & Technology Law Review

Pre-approval clinical trials cannot possibly ensure that a drug will not have disastrous side effects once it arrives on the market. Post-approval drug safety data gathering was put in place to address this problem, but as implemented, it has not proven to be as effective as hoped. Congress recently overhauled the legislation regarding post-approval drug risk identification, and in doing so made a deliberate decision to put much of the burden of post-approval drug surveillance on the FDA through data mining. Further, the legislation gave the FDA the power to require post-approval clinical trials from drug makers only in limited …