Overview

Allison Fulton is a partner in the Life Sciences team and is based in the firm's Washington, D.C. office. Allison advises biotech, pharmaceutical, medical device, food, dietary supplement and cosmetic companies in matters relating to the development, manufacture, and marketing of products regulated by the U.S. FDA.

Areas of Practice

Allison’s areas of focus include assisting U.S. and international companies comply with premarket and postmarket FDA requirements, including product launch strategy, clinical trials, compliance with GxP (GMP, GLP, GCP), product promotion and labeling, recalls and other product safety issues.  She regularly advises clients on acquisitions of life science companies and assets, and counsels clients on a variety of life science transactions, including clinical trial and investigator agreements, manufacturing, distribution and supply agreements, quality agreements, and various service agreements involving medical product technology and IP. 

Allison also advises clients on COVID-19 matters such as emergency use authorizations (EUAs), laboratory issues including Clinical Laboratory Improvement Amendments (CLIA) and laboratory developed tests (LDTs), and state license requirements for the distribution of medical products.  Allison regularly counsels companies on preparing for FDA inspections, responding to Form 483s and Warning Letters, remediating GMP and data integrity issues, and handling adverse events and medical device reports (MDRs).

Allison has a passion for novel technologies, and advises clients on product approval and clearance strategies for innovative products, including digital health technologies, precision medicine, and combination products. She has led numerous internal investigations involving allegations of product tampering, non-compliance with GMP, and off-label promotion.  Allison acts as FDA counsel on civil litigation matters, such as false advertising and False Claims Act litigation.

Prior to her legal career, she worked as a software engineer where she specialized in software validation.

Allison earned her law degree from the University of Texas School of Law, where she was the managing editor of the Texas Intellectual Property Law Journal. She received her B.S. in Industrial Engineering from Northwestern University.

Allison devotes her pro bono practice to assisting veterans obtaining benefits for service-connected disabilities.

Honors

Honors

Shortlisted for Regulatory Attorney of the Year: FDA Pharmaceutical, LMG Life Sciences, 2021

Leading Life Sciences Lawyer - FDA Medical Device and FDA Pharmaceutical, LMG Life Sciences, 2021-2022

Best Lawyer in America, Best Lawyers, 2021-2023

“Life Sciences Star” – FDA Medical Device and FDA Pharmaceutical, LMG Life Sciences, 2018-2019

Insights

Articles

  • "Submitting a new 510(k) for software changes: FDA guidance and an evolving pathway for digital health," Digital Health Legal, January 2018
  • "FDA’s Streamlined Requirements For Combination Products," Law360, January 2017
  • "Additive manufacturing and 3D printing: US FDA’s proposed draft guidance and industry perspectives," Journal of Medical Device Regulation, November 2016
  • "5 Takeaways From FDA Medical Device Data System Guidance," Law360, August 2014

  • "New Draft Guidance Would Clear Regulatory Hurdles for Developers," BNA’s Medical Devices Law & Industry Report, July 2014

Privacy Law Blog Posts

Cannabis Law Blog

FDA Law Blog Posts

Healthcare Law Blog Posts

Media Mentions

Speaking Engagements

  • Speaker, "Ensuring Regenerative Therapy Product Compliance with FDA," FDLI Regenerative Medicine: Regulatory, Legal, and Compliance Challenges for Cell and Gene Therapies Conference, June 8-9, 2021
  • Speaker, "Manufacturing and Quality System (QS) Regulation," FDLI Introduction to Medical Device Law and Regulation Conference, March 2-4, 2021
  • Speaker, "Innovative and Breakthrough Devices and Diagnostics and Evolving Regulatory Pathways," FDLI 2020 Annual Conference, October 6, 2020
  • Speaker, "Medical Device Manufacturing and The Quality System Regulation,” FDLI Introduction to Medical Device Law and Regulation, April 8, 2020
  • Speaker, “The Long-Term Effects of COVID-19 on Life Sciences Companies,” FDLI Law Over Lunch, April 22, 2020
  • Speaker, "Drug and Biologics Advertising and Promotion 101,” The American Conference Institute (ACI) 36th Annual FDA Boot Camp, San Francisco, CA, June 24, 2020 
  • Speaker, "Health Hazard Evaluations” and “Measuring the Effectiveness of Your Complaint Handling System,” AdvaMed Medical Device Complaints, MDRs and Recalls Workshop, Washington, D.C., Feb. 11, 2020 
  • Speaker, "Food and Drug Topics for Holiday Parties: News from 2019 and Predictions for 2020," FDLI Law Over Lunch, December 17, 2019

Digital Media

Education

J.D., The University of Texas School of Law, 2005, with honors

B.A., Northwestern University, 1999

Admissions

  • District of Columbia
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