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Sachs The Health Subcommittee of the House Energy & Commerce Committee held a hearing last week on the FDA’s proposed draft guidance regarding laboratory-developed tests (LDTs), as part of its “21st Century Cures” initiative.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 Diana R. H. Winters [Cross-posted on HealthLawProfBlog.] There was an article a couple of weeks ago in the New York Times about “engineered foods,” and how “a handful of high-tech start-ups are out to revolutionize the food system by engineering ‘meat’ and ‘eggs’ from pulverized plant compounds or cultured snippets of animal tissue.” The author…
By David Orentlicher[Ed Note: Cross-posted at HealthLawProfBlog.] Reversing its previous deference to corporate speech interests, the U.S. Court of Appeals for the D.C. Circuit came down in favor of consumer protection in a July 29 decision. In American Meat Institute v. U.S. Dept. of Agriculture, the court upheld a federal government regulation requiring meat companies to disclose…
By Timo Minssen Last week I blogged about recent publications concerning the global battle against anti-microbial resistance (AMR). I did not mention a recent paper published in the June 2014 issue of Nature, which describes how European and U.S. researchers and authorities are increasingly considering clinical research in unconventional areas to fight AMR. The news-report…
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…
By Richard Epstein Cross-post from PointOfLaw. Richard A. Epstein is a professor of law at NYU Law School, a Senior Fellow at the Hoover Institution, a Senior Lecturer at the University of Chicago and a visiting scholar with the Manhattan Institute’s Center for Legal Policy. His forthcoming book is “The Classical Liberal Constitution,” from Harvard…
By Kate Greenwood Cross-Posted at Health Reform Watch At Regulatory Focus earlier this week, Alexander Gaffney wrote about what he characterized as “a torrent of studies” that FDA is conducting or has proposed conducting on prescription drug promotion, and, in particular, on direct-to-consumer advertisements. The studies include, among others, a survey study aimed at sussing out “the influence of DTC advertising in…
By Mary Ann Chirba, J.D., D.Sc., M.P.H. and Alice A. Noble, J.D., M.P.H. Stem cells have been an endless source of fascination and controversy since Dolly the sheep was cloned in 1996. This month’s announcement of a cloned human embryo from a single skin cell [1] came on the heels of Sir John B. Gurdon…
