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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.  

  • 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

  • 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.
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  • FDA's Stem Cell Oversight Faces Pivotal Test in DC Circ.
    Law360 | October 22, 2013
    Washington, DC, Health Services and Life Sciences partner Areta Kupchyk discusses the importance of a DC Circuit case focused on the U.S. Food and Drug Administration’s power to regulate stem cell therapy.
  • 5 Takeaways from FDA's Unique Device ID Rule
    Law360 | September 27, 2013
    Washington, DC, Health Services and Life Sciences partner Areta Kupchyk comments on the U.S. Food and Drug Administration’s final rule on unique device identification.
  • Plan B Saga Exposes FDA to Drug-Approval Suits
    Law360 | June 19, 2013

    Washington, DC, Health Services and Life Sciences partner Areta Kupchyk discusses the U.S. Food and Drug Administration’s battle against wider access to Plan B emergency contraception.

  • Enforcement Trends Related to Executive Liability in Health Care Investigations
    Bloomberg BNA Health Care Fraud Report | June 12, 2013

    A team of New York City attorneys, including Health Services practice group leader Michele Masucci, Government Investigations & White Collar Defense partners David Feldman and Sean Haran, Government Investigations & White Collar Defense senior associate Ashley Baynham, and Commercial Litigation associate Devon Haft Little discuss recent enforcement trends under the False Claims Act and the Food, Drug and Cosmetic Act. The article also provides guidance for corporate executives on how best to address this new enforcement focus.

  • FDA Cracking Down on Compounders at Historic Pace
    Law360 | April 22, 2013

    Washington, DC, health services and life sciences partner Areta Kupchyk provides commentary in this feature article discussing the U.S. Food and Drug Administration’s efforts to police the compounding pharmacy sector.

  • Medical Apps Get the Once Over from the FDA
    Marketplace | March 29, 2013

    Washington, DC, Health Services and Life Sciences partner Areta Kupchyk discusses mobile medical apps and the FDA’s guidelines for approval.

  • FDA Seeks to Damp Criticism Over Mobile Health App Proposals
    Reuters | March 21, 2013

    Washington, DC, Health Services and Life Sciences partner Areta Kupchyk discusses the U.S. Food and Drug Administration’s plans for regulating certain health care apps used on smartphones and tablets.

  • FDA's New Safety Reports Raise Tort Risks for Device Cos.
    Law360 | March 8, 2013

    Washington, D.C. health services and life sciences partner Areta Kupchyk discusses the Food and Drug Administration’s draft guidance intended to clarify when a change to a medical device should be considered a “recall” versus a “product enhancement.”

  • FDA's Authority to Regulate Pharmacy Compounding: Who's Responsible?
    Corporate Compliance Insights | January 16, 2013

    Washington, DC, Health Services and Life Sciences partner Areta Kupchyk authored this column on the enforcement authority of the Food and Drug Administration (FDA) to regulate the creation of a particular pharmaceutical product to fit the unique needs of a patient. Click here to read the article.

  • FDA Marketing Rules Stretch to Drugmakers' Media Pitches
    Law 360 | November 13, 2012

    Washington, DC, Health Services and Life Sciences partner Areta Kupchyk comments on the standard practice of the U.S. Food and Drug Administration to reprimand companies for any marketing efforts that seem to be unfair or misleading regardless if they are directed at consumers or the media.

  • Handling an FDA inspection: Dos, Don'ts and When to Call a Lawyer
    Corporate Compliance Insights | August 20, 2012

    Washington, DC, Health Services and Life Sciences partner Areta Kupchyk authored this column discussing how to handle a facilities investigation by the Food and Drug Administration. Click here to read the article.

  • Drug, Device, and Biotechnology Manufacturing Requirements
    Corporate Compliance Insights | July 2, 2012

    This contributed article, authored by Washington, DC, Health Services and Life Sciences partner Areta Kupchyk, discusses the importance of compliance with current good manufacturing practice regulations established and enforced by the Food and Drug Administration. Click here to read the article.

  • Off-Label Communications: The FDA's Proposed Approach
    Product Liability Law & Strategy | July 1, 2012

    This article, authored by Washington, DC, Health Services and Life Sciences partner Areta Kupchyk and Buffalo Products associate Tracey Ehlers, discusses the Food and Drug Administration guidance addressing how drug, biologics, and medical device manufacturers should respond to unsolicited requests for off-label information, including—for the first time—communications via the Internet and social media.

  • Comment: FDA's Draft Guidance on Social Media and Off-Label Communications
    Bloomberg BNA Social Media Law & Policy Report | June 19, 2012
    Washington, DC, Life Sciences and Health Services partner Areta Kupchyk authored this article discussing the Food & Drug Administration’s long-awaited draft guidance on off-label use communications by drug, biologics, and device companies including, specifically, electronic communications using the Internet and social media.
  • The Park Doctrine and AIP: Two Little-Known But Powerful FDA Enforcement Tools
    Corporate Compliance Insights | April 17, 2012

    Washington, DC, Health Services and Life Sciences partner Areta Kupchyk authored this column addressing two enforcement tools used by the Food and Drug Administration (FDA) in response to violations. Click here to read the article.

  • FDA’s Draft Guidance on Social Media and Off-Label Communications
    Bloomberg BNA | January 25, 2012
    This contributed article, authored by Washington, DC, Health Services and Life Sciences partner Areta Kupchyk, discusses the draft guidance issued by the FDA about off-label use communications by drug, biologics, and device companies including, specifically, electronic communications using the Internet and social media.

Ideas

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

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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

Legislative proposal seeking to overhaul "misleading" food labeling
Food Safety & Litigation Alert | September 20, 2013

FDA moves urgently to restrict the use of Fecal Microbiota Transplants for the treatment of diseases
FDA Alert | July 22, 2013

FDA asks medical device industry to identify and mitigate cyberattack risks
Pharmaceutical, Medical Device & Life Sciences Alert | June 18, 2013

Enforcement Trends Related to Executive Liability in Health Care Investigations
June 12, 2013

Recall or product enhancement? Medical device manufacturers invited to comment on proposed FDA guidance
Pharmaceutucal, Medical Device & Life Sciences Alert | February 26, 2013

FDA registration renewal required — must be submitted by January 31
Beverage Alcohol Brief | January 10, 2013

Webinar Recording: The First Amendment and Off-Label Promotion: Understanding the Implications of U.S. v. Caronia
Originally recorded December 5, 2012 | December 6, 2012

FDA seeks comments before making custom device policy changes required by Congress
FDA/Health Alert | November 20, 2012

The new medical device excise tax: Four things to consider before 2013
Tax Alert | November 16, 2012

Federal regulation of pharmacy compounding: FDA enforcement poses new risks to pharmacists and health care providers
FDA Alert | November 2, 2012

Webinar Recording: Knock Knock: Are you Prepared When the FDA Shows Up at Your Door?
Originally recorded September 27, 2012 | October 2, 2012

The FDA bans Bisphenol A in baby bottles and children's cups—the attention may now turn to other products
Products: Class Action, Trade & Inidusty Representation Alert | July 19, 2012

Will your products be subject to the new 2.3% Federal Excise Tax on "taxable medical devices" next year?
Tax Alert | May 23, 2012

FDA Denies Petition to Ban BPA
Products: Class Action, Trade & Industry Representation Alert | April 3, 2012

FDA issues biosimilar draft guidance
FDA Alert | February 28, 2012

FDA's draft guidance on social media and off-label communications
FDA Alert | January 26, 2012

Webinar Recording: Recent Developments in the Regulation of Off-Label Communications
January 17, 2012

Webinar Recording: Counting calories: Impact of new FDA menu guidelines
June 29, 2011

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FDA