By Ryan Abbott Actavis is back in the spotlight regarding its allegedly anticompetitive behavior. Last month, the U.S. District Court for the Southern District of New York issued an injunction against Actavis and its subsidiary, Forest Laboratories LLC based on the New York Attorney General’s “product hopping” suit. The suit concerns Actavis’ attempt to extend monopoly…
By Joan H. Krause [Cross-posted at HealthLawProf Blog] Whether it be a social media campaign to convince a company to provide an experimental anti-viral drug to a young cancer patient suffering from a life-threatening infection or the debate over appropriate treatment for high-profile Ebola cases, access to potentially life-saving but unapproved medications remains a controversial…
The 2015 edition of the International Compilation of Human Research Standards has just been released and is available online. The Compilation features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 113 countries, as well as standards issued by a number of international and regional organizations. Six new countries are included…
By Arthur Caplan Art Caplan has a new piece on hyperbaric oxygen therapy over at NBC News: Hyperbaric oxygen therapy. Have you ever heard of it? The Internet sure has. Centers and clinics tout the benefits of sitting in a tank breathing 100 percent oxygen at higher than atmospheric pressure for treating autism, infant brain…
By The Petrie-Flom Center An op-ed from our friends Mark Barnes and Barbara Bierer at Harvard’s Multi-Regional Clinical Trials Center on recent legal changes to India’s clinical trial requirements, arguing that using the clinical trial context to promote a social or political policy agenda in India may sacrifice scientific integrity in the service of social justice. A…
[Blogger’s Note: I am very pleased to share this post by my colleague at Seton Hall Law, Carl Coleman. This post was cross-posted at Health Reform Watch.] By Carl H. Coleman With well over 5,000 global deaths from Ebola already reported, drug developers are working fast to begin human clinical trials of promising experimental treatments. Earlier this month,…
Check out the November 14th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.
By Timo Minssen The current Ebola outbreak already attracted much attention on “Bill of Health” resulting in some excellent blogs on a horrible topic. While it is evident that the current health crisis requires both immediate responses and more sustainable changes in health care policy, research and regulation, medicines regulators are collaborating internationally to find innovative…
By Timo Minssen The following information has been extracted from the webpage of the BioBanking and Molecular Resource Infrastructure of Sweden on the course Biobanking as a Resource for Biomedical Research, February 9-13, 2015 at Karolinska Institutet (Stockholm). Purpose and Goal Biobanks constitute a powerful resource in medical research with access to millions of samples and associated data…
By Timo Minssen I have just been informed that a new call for proposals for the 2016 Brocher Foundation residencies has been launched. I can warmly recommend this splendid opportunity to any researcher or group of researchers in the fields of Bioethics, Medical Anthropology, Health Economics, Health Policy, Health Law, Philosophy of Medicine and Health, Medical Humanities, Social Science Perspectives on Health, Medical Ethics,…
