Overview

Allison Fulton is a partner in the Life Sciences and FDA Team in the firm's Washington, D.C. office. She advises life sciences companies, including pharmaceutical, medical device, dietary supplement, food and cosmetic companies, in matters relating to the development, manufacture and marketing of products regulated by the U.S. Food and Drug Administration (FDA).

Areas of Practice

Allison’s areas of focus include assisting U.S. and international companies with complying to pre-market and post-market FDA requirements, including marketing authorization, clinical trials, compliance with GxP, product promotion and labeling, recalls and other product safety issues. She regularly advises companies on preparing for FDA inspections, responding to FDA Form 483s and Warning Letters, remediating GMP and data integrity issues and handling adverse events and medical device reports (MDRs). Allison also provides regulatory advice during acquisitions of life science companies, and counsels clients on a variety of life science transactions, including supply agreements, quality agreements and product licenses.

Allison is passionate about 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 attending law school, Allison was a software engineer, specializing in software validation. She 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 a B.S. degree in Industrial Engineering from Northwestern University.

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

Honors

Honors

“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  • "Additive manufacturing and 3D printing: US FDA’s proposed draft guidance and industry perspectives," Journal of Medical Device Regulation, November 2016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

FDA Law Blog Posts

Healthcare Law Blog Posts

Speaking Engagements

  • 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

Events

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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