FDA



In an environment of increasingly complex and rapidly changing FDA regulations and aggressive enforcement actions, we help life sciences companies remove obstacles in their path and quickly get over the hurdles.

Our approach

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.

Who we work with

  • Biotech, medical device, and pharmaceutical companies
  • Hospitals and health care institutions
  • Foreign manufacturers of FDA-regulated products
  • Leading universities and academic medical centers
  • Manufacturers and importers of food and food-related products

Biosimilar battle heads to high court

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).

The FDA's Priority List For 2016

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.

Putting Out a Call on Added Sugars

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.

Outgoing FDA Chief's Contentious Tenure Empowered Agency

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.

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