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FDA

Nixon Peabody’s FDA Regulatory team has the experience and knowledge to counsel national and international pharmaceutical, medical device, and biotechnology companies as they navigate significant regulation and scrutiny. Our services enable clients to comply with the complex structure of laws and regulations that impact every stage of product development and distribution, including laws and regulations enforced by the U.S. Food and Drug Administration , the Federal Trade Commission, the Securities and Exchange Commission, the Patent and Trademark Office, the Drug Enforcement Agency, the U.S. Department of Agriculture, and each of their state equivalents.

Our FDA practice is focused on:

  • Product development, review, and approval
  • Matters related to clinical research and human subject protection
  • Regulatory compliance
  • Enforcement risk
  • Development and commercialization of products
  • Market protection and exclusivity issues
  • Marketing and post-marketing issues
  • Off-label promotion
  • Adverse events
  • Recalls
  • Response to 483s and warning letters
  • cGMP requirements
  • Development of regulatory compliance programs and training programs
  • The import/export of FDA-regulated products

While our team can advise on the full range of pharmaceutical and medical device technologies, we offer particular experience with development of cutting-edge technologies such as stem cells, gene therapy, human tissue, xenotransplantation, pharmacogenomics, biomarkers, as well as drug/device combination products.

Thought Leadership/Alerts

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

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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

Food Safety Legislation Signed Into Law
Food Safety and Litigation Alert | January 6, 2011

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Press

Media Clips

  • 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.

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  • 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.

  • 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.

  • 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.
  • 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.

  • 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.
  • FDA Taking New Look at Medical-device Review Process
    The National Law Journal | March 14, 2011
    This article, authored by Washington, DC, counsel and leader of the firm’s FDA Regulatory practice Seth Mailhot, discusses the U.S. Food and Drug Administration’s continuing reviews of and revisions to its most commonly used medical-device marketing authorization process, known as the 510(k) process.
  • Closeout Letters Slow to Come After Warnings Are Resolved
    FDANews | December 1, 2010
    The feature story addresses the slow process by which regulated companies are receiving a closeout letter. Washington, DC, counsel and leader of the firm’s FDA Regulatory practice Seth Mailhot provides commentary in the piece.
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Events

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

Webinar: Knock Knock: Are you Prepared When the FDA Shows Up at Your Door?
September 27, 2012

Webinar: The FDA and Medical Products: Practices and Proposals for Internet and Social Media
July 10, 2012

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FDA