By Deborah Cho Last summer, the FDA reversed its previous decision that required researchers to file INDs for fecal transplants to treat Clostridium difficile. This decision came without much official explanation as to the reasoning behind the reversal, but can be understood as a result of the unusually high success rates of fecal transplants in treating the…
Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm. This year we will…
By Jeffrey Skopek For those interested in the FDA’s decision to regulate 23andMe’s direct-to-consumer genetic testing service, it is worth reading a recent comment in Nature by Robert Green and Nita Farahany. The piece raises two core objections to the FDA’s decision that deserve further attention. One objection is that the FDA’s decision runs contrary to “the historical…
Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm. This year we will…
By Ching-Fu Lin The Food and Drug Administration’s (FDA) proposed rule on Accreditation of Third Party Auditors to implement the Food Safety Modernization Act (FSMA) has given rise to many questions on both domestic and international levels. The proposed rule is intended to establish a program for recognition of accreditation bodies and accreditation of third-party auditors…
Efthimi Parasidis explores JAMA’s spotlight on FDA, Drugs, and Devices at The Conversation, a London-based news outlet. Click here to go to the article.
By Deborah Cho I would highly recommend reading the Stanford Social Innovation Review’s recent article An Rx for Surplus Meds featuring the Dispensary of Hope, a brilliant model of providing prescription medications to those who need but can’t afford them. In a nutshell, the Dispensary of Hope, a not-for-profit enterprise, collects unused medication samples from participating physicians and pharmacies across the…
This conference will bring together scholars to discuss a range of issues related to the Food Safety and Modernization Act, including FSMA and risk regulation strategy; regulating farm production; benefits, challenges, and gaps in FSMA’s approach; and international issues and trade implications. Speakers include: KEYNOTE: Peter Barton Hutt, Harvard Law School/Covington & Burling – The Food Safety…
By Kuei-Jung Ni I am pleased to post that my new book, “Science and Technology in International Economic Law: Balancing Competing Interests” (co-edited with Professor Bryan Mercurio at the Chinese University of Hong Kong), was recently published by Routledge. In addition to the introduction, the book includes thirteen articles written by scholars from the Asia-Pacific…
By Jeffrey Skopek Last week, the Food and Drug Administration finalized a long-awaited guidance document that aims to reduce non-therapeutic uses of antibiotics in livestock production and thereby limit the evolution of drug-resistant bacteria. As I discussed in a previous post, the use of antibiotics in livestock production is often not for the therapeutic purpose…
