Book Launch: “Human Subjects Research Regulation: Perspectives on the Future” Wednesday, October 22, 2014 12:00 PM – 1:00 PM Harvard Law School Library Langdell Hall 4th Floor, Caspersen Room, 1557 Massachusetts Ave. This event is free and open to the public. Lunch will be served. For a list of our panelists, please visit our website. MIT Press recently…
Emerging Issues and New Frontiers for FDA Regulation October 20, 2014 8:00 AM – 5:00 PM Alston & Bird, The Atlantic Building, 950 F Street, NW, Washington, DC 20004-1404 Registration is now open online. A limited number of free seats are available to Harvard affiliates. For more information or to request a seat, please email us…
Emerging Issues and New Frontiers for FDA Regulation October 20, 2014 8:00 AM – 5:00 PM Alston & Bird, The Atlantic Building, 950 F Street, NW, Washington, DC 20004-1404 Symposium co-sponsored by the Food and Drug Law Institute (FDLI) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Please join the…
By Rachel Sachs The Health Subcommittee of the House Energy & Commerce Committee held a hearing last week on the FDA’s proposed draft guidance regarding laboratory-developed tests (LDTs), as part of its “21st Century Cures” initiative. The hearing, which can be viewed online (here and here), featured representatives from the FDA, industry, and research organizations….
By Timo Minssen In Part II of this blog on legal issues relating to the revival of phage therapy I discussed the US Supreme Court’s decisions in Myriad and Prometheus, which might present major obstacles to the patentability of phage-related technology (a more detailed analysis of the Myriad and Prometheus decisions is available here). Yet,…
By Timo Minssen Please find attached a ppt presentation on “New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives” given on March 7, 2014 at the Broad Institute of MIT and Harvard. The presentation was followed by a discussion moderated by US patent attorney Melissa Hunter-Ensor, Partner at Saul Ewing, Boston. I…
By Jonathan J. Darrow In January, the Food and Drug Administration (FDA) approved the use of the PillCam COLON 2 as a minimally-invasive means of viewing the colon, a development that is sure to be welcomed by U.S. patients who currently undergo an estimated 14 million colonoscopies each year. While the approval represents a major step…
So You Want to be a Technology Developer… The roots of Skype go back to one email. If that email hadn’t been sent, the world today might be different. In general, technology development is not something that “just happens” — instead, it’s a result of particular actions by individual people. Moreover, the responsibility of technology…
By Julian Urrutia In my last post I promised I would provide details about the new piece of statutory legislation that was recently enacted by the Colombian Congress on the right to health, but first I should talk a little more about the prior jurisprudence that set the stage for it–especially since there’s so much…
By Nadia N. Sawicki Loyola University Chicago’s Stritch School of Medicine recently announced that it is accepting applications from DREAMers – undocumented immigrants who are eligible for the Deferred Action for Childhood Arrivals (DACA) program, which grants qualified applicants a two-year, renewable authorization to remain and work within the United States. This news was met with…
