In my last two posts, I emphasized the relationship between regulatory capacity building, harmonization, and cooperation using examples from the CDC’s and USAID’s experiences in Liberia and Laos. Yet so far as global supply chains go, the FDA is now and since its establishment has been the most important agency with respect to both cooperation […]

In my last post, I observed that there was a dilemma posed by the current system of producing and moving medicines and vaccines from the developed, wealthy countries of North America, Europe and the Pacific Rim to low-resource countries in Asia, Africa and South America. The public health urgency of distributing medicines and vaccines often […]

My last several posts dealt with the complicated relationship between the Ebola outbreak in Guinea, Liberia, and Sierra Leone and the International Health Regulations that were adopted in 2005 (with an effective date in 2007) in order to address exactly such a threat. The overwhelming consensus is that they failed to effectively manage the outbreak […]

Although the sharp drop in the number of new Ebola infections has, worryingly, appeared to level off, the international community has made significant progress toward raising funds toward the response, developing and now undertaking widespread testing of vaccines, and implementing measures meant to control the worldwide spread of the disease. All of this leaves the […]

In my last post, I introduced the topic of the strengths and weaknesses of the International Health Regulations (2005) as they have been exposed by the world’s response to the Ebola outbreak generally and by the World Health Organization’s response specifically. In this post I’ll address both a strength and a weakness: Annex 2 to […]

I’m delighted to join the other contributors to the Yale Journal on Regulation’s Notice and Comment Blog. My academic and professional time is more or less divided between the regulatory activities of the World Health Organization, particularly its activities under the 2005 International Health Regulations (IHR), and agencies under the U.S. Department of Health and […]