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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

Media Clips

  • 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 5, 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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  • FDA's Biggest New Policies of 2014: Midyear Report
    Law360 | July 28, 2014
    Washington, DC, Health Care and Life Sciences partner Areta Kupchyk is quoted in this forward-looking feature story on new rules and guidance from the U.S. Food and Drug Administration making waves for drug and device makers.
  • Personalized Medicine Changes the Rules of the Play (Personoitu Laaketiede Muuttaa Pelisaantoja)
    Mediuutiset (Finland) | March 21, 2014
    In this Finnish health care publication, Boston Patents counsel Leena Karttunen Contarino provides commentary on how the FDA defines personalized medicine and about the FDA’s attempts to handle personalized medicine drugs and devices in an integrated process.
  • Life Sciences Regulation and Legislation to Watch in 2014
    Law360 | January 1, 2014
    Washington, DC, Health Services and Life Sciences partner Areta Kupchyk discusses FDA’s involvement in laboratory-developed testing, momentum on biosimilars, and possible further guidance on developing tailored medications.
  • Personalized Medicine Providers, FDA Has Your Back
    Law360 | December 8, 2013
    Boston Patents counsel Leena Karttunen Contarino and Washington, DC, Health Services and Life Sciences partner Areta Kupchyk authored this column discussing the U.S. Food and Drug Administration’s comprehensive personalized medicine report.


New look for nutrition facts label
Food, Beverage & Agriculture Alert | May 25, 2016

FDA to reconsider meaning of "healthy" on food labels
Food, Beverage & Agriculture Alert | May 12, 2016

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Congress stirred into action on GMO labeling
Food, Beverage & Agriculture Alert | February 29, 2016

What's trending on NP Privacy Partner
NP Privacy Partner | January 22, 2016

User fees, biosimilars on FDA priority list for 2016
FDA Alert | January 5, 2016

FDA releases precisionFDA to allow for collaboration for NGS
FDA Alert | January 4, 2016

FDA extends comment period on "natural" food labeling
FDA/Food, Beverage & Agriculture Alert | December 29, 2015

FDA releases draft guidance on IND sponsor communication best practices
FDA Alert | December 28, 2015

FDA invites comments on "natural" food labeling
FDA/Food, Beverage & Agriculture Alert | November 10, 2015

Federal Court disagrees with FDA, allows drug manufacturer to proceed with truthful, non-misleading off-label promotion of drug
Government Investigations and White Collar Defense Alert | August 11, 2015

FDA's "Same Surgical Procedure" Draft Guidance Could Stifle Use of Autologous Stem Cell Therapies
Health Care Alert | June 17, 2015

FDA releases updated guidance on MDDS, medical imaging storage and communications devices, and mobile apps
FDA Alert | February 26, 2015

California Federal Court Takes First Stab At False Advertising Claims Involving Prescription Drugs After POM Wonderful
IP Law Alert | October 21, 2014

What's trending on NP Privacy Partner
NP Privacy Partner | September 26, 2014

The FDA announces long-awaited draft social media guidance for drug and medical device industry
FDA Alert | June 18, 2014

Fifth Circuit slams the door shut on innovator liability and rejects attempted end-run around Mensing
Life Sciences Alert | May 23, 2014

Draft rule from FDA threatens to destroy spent grain exemption enjoyed by brewers
Beverage Alcohol Alert | April 23, 2014

The FDA proposes expansion of five-year marketing exclusivity for new chemical entities
Pharmaceutical, Medical Device and Life Sciences Alert | March 6, 2014

Court rejects FCA liability theory based on FDA manufacturing standards
Government Investigations & White Collar Defense Alert | March 4, 2014

Federal court keeps stem cell products under FDA's rule
Pharmaceutical, Medical Device And Life Sciences Alert | February 11, 2014

FDA: Interested parties have 60 days to weigh in on tentative determination regarding trans fats
Food Safety & Litigation Alert | November 8, 2013

What You Need to Know About the Personalized Medicine Report by FDA
FDA Law Alert | November 5, 2013

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