By Daniel Aaron The Trump Administration has retreated from proposed tobacco regulations that experts generally agree would benefit public health. The regulations would have included a ban on flavored e-cigarettes, a favorite of children who use e-cigarettes. Currently millions of youth are estimated to be addicted to e-cigarettes. The rules also could have reduced nicotine…
By Rahul Nayak Interested in learning more about pharmaceutical policy? Curious about the role of the FDA in ensure safe and effective drugs reach the market? Wondering why drug prices are so high in the US? Readers of my prior posts may enjoy learning more about these topics! Check out a free HarvardX online course,…
By Rebecca Friedman A debate has been brewing between the cattle milk industry and the plant-based milk industry (producing drinks made from ingredients such as almonds, soy, and rice), regarding what products can actually be labeled “milk.” This has motivated the Federal Drug Administration to review how milk is defined under federal regulations, in order to…
Headspace is paving the way for the first FDA-approved prescription meditation app. Developers behind the mindfulness smartphone app, which has over 30 million users, are creating a new product under Headspace Health that will begin clinical trials this summer, in hopes of clearing FDA approval by 2020. The team is investigating how the app can…
By Oliver Kim After an initial procedural hiccup, the House of Representatives passed a modified version of a federal “right to try” bill, legislation that would allow pharmaceutical companies to bypass the federally-prescribed clinical trial process to allow terminally ill patients to try experimental drugs. Similar legislation passed the Senate as part of a horse-trade…
By Mason Marks FDA Commissioner Scott Gottlieb issued a statement on Tuesday about the controversial plant Mitragyna speciosa, which is also known as kratom. According to Gottlieb, kratom poses deadly health risks. His conclusion is partly based on a computer model that was announced in his recent statement. The use of simulations to inform drug…
By Timo Minssen Join us in wonderful Copenhagen at our CeBIL Kick-Off Conference: ”Innovation Gaps on Life Science Frontiers? From Antimicrobial Resistance & the Bad Bugs to New Uses, AI & the Black Box”. The Conference marks the start of the Novo Nordisk Foundation’s Collaborative Research Programme in Biomedical Innovation Law which is carried out…
By Timo Minssen I am happy to announce the publication of our new working paper on “Patenting Bioprinting Technologies in the US and Europe – The 5th element in the 3rd dimension.” The paper, which has been co-authored by Marc Mimler, starts out by describing the state of the art and by examining what sorts of bioprinting inventions…
By Wendy S. Salkin I. Our Bodies, Our Body Politic On March 30, at a town hall meeting in Green Bay, Wisconsin, an audience member asked then-presidential-hopeful Donald J. Trump: “[W]hat is your stance on women’s rights and their right to choose in their own reproductive health?” What followed was a lengthy back-and-forth with Chris Matthews….
By Jonathan Larsen, JD, MPP and Adrienne R. Ghorashi, Esq. The US Food and Drug Administration (FDA) approved the first biosimilar for use in the United States in March 2015. The approval came after several years of regulatory process development authorized by the Biologics Price Competition and Innovation (BPCI) Act of 2009, a component of…
