At least 79 cases of infection tied to Sorin heater-cooler units in the U.S. and worldwide have been reported to the FDA since 2010, including 12 deaths. Those numbers are expected to rise.
In many aspects, witnesses recognized that a light regulatory touch was called for, as the FDA, FTC and Congress itself could not keep pace with the rate of industry innovation.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
"It'll be quite a few years before we have a handle on this technology and how it's going to be regulated by the FDA, if at all," a Washington lawyer said at a recent Food and Drug Law Institute conference.
Several diagnostic companies use the "laboratory developed test" loophole to avoid regulation and market tests without FDA approval, for better or worse.
By Karla L. Palmer – The Energy and Commerce Committee’s Subcommittee on Health (chaired by Representative Joe Pitts (R-PA)), has scheduled a hearing for Monday, April 7, 2014, at 3:00 p.m. in room 2123 of the Rayburn House Office Building. The hearing is titled “Improving Predictability and Transparency in DEA and FDA Regulation.” Industry and […]
By Riëtte van Laack – In addition to the many (more than 20,000) comments to FDA on the draft rules regarding Produce and Preventive Controls implementing the Food Safety Modernization Act (“FSMA”) (Docket Nos. FDA-2011-N-0920 and FDA-2011-N-0921), FDA has received a flurry of letters from Congress – see here, here, here, and here – expressing […]
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.