- J.D., The University of Texas School of Law, 2005, with honors
- B.A., Northwestern University, 1999
- District of Columbia
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.
- “Life Sciences Star” – FDA Medical Device and FDA Pharmaceutical, LMG Life Sciences, 2018-2019
Podcasts & Webinars
- Law360, November 4, 2019
- Food Dive, October 17, 2019
- MD+DI, September 5, 2019
- Food Dive, August 15, 2019
- Walking the Regulatory Line of CBD in CosmeticsCosmetics & Toiletries, July 2019
- Law360, June 4, 2019
- "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
- "New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning," September 30, 2019
- "Tips for When to Consider Legal Review of Quality System Investigations," September 23, 2019
- "FDA’s New Safety and Performance Based Pathway for Medical Devices Reflects a More Modern Approach to Finding Substantial Equivalence," September 20, 2019
- "Regulating E-Cigarettes Remains “Top Priority” For FDA," July 12, 2019
- "Medical Devices – Artificial Intelligence and Reactions to FDA’s Proposed Oversight," June 25, 2019
- "Location Matters – Manufacturing Insights from FDA’s Annual Report on Drug Quality," May 20, 2019
- "AAFCO Issues Updated Guidelines Regarding Hemp in Animal Food," May 8, 2019
- "FDA Update: Recent Trends and a New Regime," April 19, 2019
Healthcare Law Blog Posts
- Law360, October 28, 2019
- Law360, January 23, 2019
- Roundtable and Networking EventSheppard Mullin, Washington D.C., December 5, 2019
- Food Advertising, Labeling, and Litigation Conference: For the Food and Dietary Supplement IndustriesFood and Drug Law Institute, September 26, 2019
- Hemp-CBD: Enabling Growth by Managing Legal RisksCelesq Webinar, September 25, 2019
- July 17, 2019