FDA Regulatory

McGuireWoods’ U.S. Food and Drug Administration (FDA) Regulatory Team provides comprehensive strategic consulting, compliance, and litigation support for manufacturers, importers, distributors, sellers, healthcare providers, financers, trade associations, and consumers for all of the goods FDA’s regulates. McGuireWoods believes that a holistic, multidisciplinary approach to FDA-regulated products is the real-world way to navigate your business. Our goal is to become an integral and efficient component of your business rather than detached outside counsel.

The U.S. Food and Drug Administration (FDA) is a scientific, regulatory, and public health agency that has regulatory authority over most food products (other than meat, poultry, and egg products) and dietary supplements and ingredients, human and animal drugs, biologics, therapeutic products of biological origin, cellular and tissue-based products, cloning, medical devices, radiation-emitting products, cosmetics, animal feed, and tobacco products. These items account for about 20 cents of every dollar spent by consumers. Some of these products may have “generic” or interchangeable versions, such as generic drugs, which are pharmaceutically and therapeutically equivalent, or similar versions, such as 505(b)(2) new drugs or biosimilars. In some instances, the FDA must approve or clear certain products prior to marketing, but in others, industry may market immediately but is expected to follow the FDA’s regulatory scheme—with the potential for enforcement consequences for noncompliance. Complicating this scheme is the potential for overlap with other government agencies, such as the Federal Trade Commission, the U.S. Department of Agriculture, the U.S. Patent and Trademark Office, and the Nuclear Regulatory Commission.

Given the depth and breadth of the agency’s rulemaking and enforcement authority, it is crucial that each of these industry sectors, along with healthcare providers, are aware of and comply with the FDA’s regulations, policies and guidance documents. McGuireWoods’ FDA Regulatory Team features multi-disciplinary lawyers and former regulators practicing in multiple offices throughout key offices in the United States and Europe. The team draws on the firm’s significant FDA-related experience, including that of lawyers from McGuireWoods LLP and consultants from McGuireWoods Consulting with the following credentials:

  • Pharmacists, engineers, and science professionals
  • Former in-house counsels to food, drug, and medical device companies
  • Former FDA regulatory counsel and counsel to other overlapping agencies
  • Former legislative staff, including health policy advisors for key Congressman, involved in healthcare reform, reimbursement, and finances.

Collectively, our team’s skill set and diverse experience allows us to navigate the FDA’s often complex and continually changing regulations and guidelines. We work with clients on all aspects of FDA-related matters, including:

  • Product development and clinical development strategies and protocols and labeling, including preparing for and assisting with internal and public FDA meetings, including advisory committee meetings
  • Establishment licenses and accreditation planning and reviews
  • Life cycle management and patent portfolio analyses including analyses in preparation for litigation
  • Engaging lawmakers at both the Federal and State level to ensure legislative threats and opportunities are properly evaluated and addressed in a way that provides maximum client benefit
  • Responding to broad public policy initiatives underway at FDA, influencing the regulatory process in order to optimize the regulatory environment in which our clients operate
  • Development of advocacy materials and campaigns designed to build support for client initiatives outside of the traditional legislative or regulatory channels
  • Development of pharmacovigilance and risk management programs including risk evaluation and mitigation strategies (REMS), some with elements to assure safe use (ETASU), to help mitigate risks
  • Citizen petitions, suitability petitions, and other petitions and letters to the Agency, including petitions for reconsideration and responses and related litigation
  • Product liability analysis and counseling
  • Marketing and promotion, including advertising, labeling and off-label use
  • Compliance analysis and counseling, including good manufacturing practices (cGMPs) and good clinical practices (cGCPs)
  • Regulatory analysis and counseling, with an emphasis on identifying possible FDA enforcement actions and developing strategies to limit potential investigations
  • Development, training, and implementation of internal compliance programs
  • FDA submissions, inspections and responses to FDA Form 483s, warning letters and “Dear Manufacturer” and “Dear Doctor” letters
  • Corrective action plans, including negotiation of FDA Consent Decrees, responses to FDA compliance notifications, and identification of key concerns that should be addressed to ensure ongoing compliance
  • Litigation, including defense of individuals and companies in FDA-related seizures, injunctions, grand jury investigations and criminal prosecutions; court challenges final agency action; and civil and enforcement matters at all levels of government
  • Recalls, product withdrawals, and media relations
  • Due diligence for financial transactions with FDA-regulated companies.
FDA

CONTACTS

James F. Neale Partner T: +1 434 977 2582
Angela M. Spivey Partner T: +1 404 443 5720
Results 1-1 of 1
Representative Matter

Major drug manufacturer

Assisted major drug manufacturer in negotiating with FDA, avoiding substantial product recall.
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Mark E Anderson Mark E. Anderson
Partner
434 Fayetteville Street
Suite 2600
Raleigh, NC 27601

1345 Avenue of the Americas
7th Floor
New York, NY 10105-0106

T: +1 919 755 6678
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Scott Becker Scott Becker
Partner
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 750 6016
F: +1 312 920 6135
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Ginny Boland Ginny Boland
VP, MWCAdvocacy McGuireWoods Consulting LLC
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916

T: +1 804 775 1907
F: +1 804 775 1061
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Caitlin Bradley Caitlin O. Bradley
Associate
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916

T: +1 804 775 1126
F: +1 804 698 2031
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Bryan C Brantley Bryan C. Brantley
Partner
Tower Two-Sixty
260 Forbes Avenue
Suite 1800
Pittsburgh, PA 15222-3142

T: +1 412 667 7983
F: +1 412 667 7971
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Kathleen H Dooley Kathleen H. Dooley
Partner
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146

T: +1 704 343 2347
F: +1 704 444 8755
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Christina M Egan Christina M. Egan
Partner
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 750 8644
F: +1 312 698 4502
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Christopher K Greene Christopher K. Greene
Partner
Promenade
1230 Peachtree Street, N.E.
Suite 2100
Atlanta, GA 30309-3534

T: +1 404 443 5721
F: +1 404 443 5692
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Jason S Greis Jason S. Greis
Partner
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 849 8217
F: +1 312 698 4550
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Matthew Hall Matthew Hall
Partner
11 Pilgrim Street
London EC4V 6RN
United Kingdom

T: +44 20 7632 1611
F: +44 20 7632 1638
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Steven J Keeler Steven J. Keeler
Partner
Court Square Building
310 Fourth Street, N.E.
Suite 300
Charlottesville, VA 22902-1288

1750 Tysons Boulevard
Suite 1800
Tysons, VA 22102-4215

T: +1 434 977 2512
F: +1 434 980 2259
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T:+1 703 712 5138
F: +1 434 980 2259

Stephanie Kennan Stephanie A. Kennan
Sr. VP, Federal Public Affairs McGuireWoods Consulting LLC
2001 K Street N.W.
Suite 400
Washington, DC 20006-1040

T: +1 202 857 2922
F: +1 202 828 3337
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Nathan A Kottkamp Nathan A. Kottkamp
Senior Counsel
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916

T: +1 804 775 1092
F: +1 804 698 2072
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Patrick Martin Patrick G. Martin
Sr. VP, Federal Public Affairs McGuireWoods Consulting LLC
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 849 8105
F: +1 312 698 4505
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Raj Natarajan Raj Natarajan
Partner
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146

T: +1 704 343 2330
F: +1 704 353 6147
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James F Neale James F. Neale
Partner
Court Square Building
310 Fourth Street, N.E.
Suite 300
Charlottesville, VA 22902-1288

T: +1 434 977 2582
F: +1 434 980 2263
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Stephen Older Stephen Older
Partner
1345 Avenue of the Americas
7th Floor
New York, NY 10105-0106

T: +1 212 548 2122
F: +1 212 715 2307
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Robert Plotkin Robert Plotkin
Counsel
2001 K Street N.W.
Suite 400
Washington, DC 20006-1040

1345 Avenue of the Americas
7th Floor
New York, NY 10105-0106

T: +1 202 857 1750
F: +1 202 828 2970
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T:+1 212 548 7098
F: +1 212 548 2150

Megan Rachford Meghan M. Rachford
Associate
Promenade
1230 Peachtree Street, N.E.
Suite 2100
Atlanta, GA 30309-3534

T: +1 404 443 5740
F: +1 404 443 5681
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Angela Spivey Angela M. Spivey
Partner
Promenade
1230 Peachtree Street, N.E.
Suite 2100
Atlanta, GA 30309-3534

T: +1 404 443 5720
F: +1 404 443 5792
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Helen H Suh Helen H. Suh
Senior Counsel
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 849 8248
F: +1 312 698 4532
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R. Trent Taylor R. Trent Taylor
Partner
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916

T: +1 804 775 1182
F: +1 804 225 5409
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Rachelle Thompson Rachelle H. Thompson
Partner
434 Fayetteville Street
Suite 2600
Raleigh, NC 27601

T: +1 919 755 6572
F: +1 919 755 6591
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Michael B Woodard Michael B. Woodard
Partner
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916

T: +1 804 775 4729
F: +1 804 698 2210
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Results 1-13 of 13
Event

9th Annual Pharmaceutical and Medical Device Conference

Thursday, November 16, 2017
Chicago, IL
Event

8th Annual Pharmaceutical and Medical Device Conference

November 10, 2016
Chicago, IL
Speaking Engagement

FDA News Webinar

August 17, 2016
Webinar
Speaking Engagement

The Pharmacovigilance Final Rule Summit on IND Safety Reporting

August 16-17, 2016
Alexandria, VA
Speaking Engagement

Food and Drug Law Institute webinar

June 28, 2016
FDLI Webinar
Speaking Engagement

FDLI Enforcement, Litigation, and Compliance

December 9-10, 2015
Washington, DC
Event

7th Annual Medical Device and Life Sciences Conference

November 19, 2015
Chicago, IL
Event

6th Annual Medical Device and Life Sciences Conference

November 18, 2014
Chicago, IL
Speaking Engagement

AdvaMed 2014: The MedTech Conference

October 7, 2014
Chicago, IL
Speaking Engagement

Legal and Regulatory Summit on Generic Drugs

July 24-25, 2014
New York, NY
Speaking Engagement

2014 IWLA Warehouse Legal Practice Symposium

June 18-19, 2014
Rosemont, IL
Results 1-13 of 13
Results 1-20 of 54
Show All
Article

FDA Flexes Its Muscles in Food Fights

Strategic risk and crisis management take center stage as criminalization of enforcement threatens companies and their executives

Metropolitan Corporate Counsel
March 30, 2016
Legal Alert

Patent Settlement Update for Pharmaceutical Cases in Europe

FDA Life
January 12, 2016
Legal Alert

FDA Finalizes First Two Rules Under FSMA

September 14, 2015
Legal Alert

Amarin Wins Truthful Off-Label Speech Challenge

FDA Life
August 10, 2015
Results 1-20 of 54