In recent years, we’ve watched FDA struggle with regulating new technologies, such as regenerative medicine, medical mobile apps, and even social media. And we know FDA continues to scrutinize advertising and promotional activities, especially those that appear to promote off-label use.
We’re also seeing a significant increase in foreign manufacturing facility inspections, Import Alerts, and related Warning Letters
We stay on top of these trends so that we can help clients proactively identify and avoid problems that could disrupt their business. We advise our clients on issues from product development and clinical research, to commercialization and compliance programs. We know first-hand how and why FDA takes enforcement actions and how best to respond, whether it be a voluntary recall or a response to a 483 or Warning Letter, or even a seizure or injunction.
And while we provide advice on a full range of technologies, we have particular experience in cutting-edge technologies, such as stem cell therapies and other cellular and tissue-based products, pharmacogenomics, wireless and mobile medical devices, companion diagnostics, and new biotech products.
Our FDA group works closely with our other Life Sciences practice groups to help clients comply with a panoply of complex laws and regulations carrying both civil and criminal penalties, including those enforced by the FTC, SEC, PTO, USDA, and DEA.
Los Angeles/San Francisco Daily Journal | February 15, 2017
Los Angeles IP litigation partner Shawn Hansen authored this column about an upcoming case in the U.S. Supreme Court that will deal with Biologics Price Competition and Innovation Act of 2009 (BPCIA), which was enacted as part of the Affordable Care Act (ACA).
Law360 | January 29, 2016
Chicago Health Care associates Erica Cribbs, Gretchen Harper and April Schweitzer co-authored this column discussing the Food and Drug Administration’s priorities for the year.
Food Processing | October 26, 2015
Chicago Commercial Litigation partner Jamie Robinson, a member of the Food, Beverage & Agriculture team, authored this column looking at where the FDA will end up on 'added sugars' on the new Nutrition Facts Panel.
Law360 | February 05, 2015
Washington, DC, Health Care and Life Sciences partner Areta Kupchyk is quoted in this article discussing the legacy of departing U.S. Food and Drug Administration Commissioner Margaret Hamburg.
Food, Beverage & Agriculture Alert | 05.25.16
Food, Beverage & Agriculture Alert | 05.12.16
Food, Beverage & Agriculture Alert | 02.29.16
NP Privacy Partner | 01.22.16
FDA Alert | 01.05.16
FDA Alert | 01.04.16
FDA/Food, Beverage & Agriculture Alert | 12.29.15
FDA Alert | 12.28.15
FDA/Food, Beverage & Agriculture Alert | 11.10.15