Allison Fulton

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

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

Digital Media

Nota Bene Episode 71: Shifting Regulatory Landscapes at the FDA: Cannabis, Vaping and Intelligent Medical Devices with Allison Fulton

Cannabis Webinar Wednesday: Getting Your CBD/Hemp Product To Market- Current Issues in Risk Management

Cannabis Webinar Wednesday: Hemp-CBD: Enabling Growth by Managing Legal Risks

Nota Bene Episode 32: A Snapshot of the FDA: Understanding the Basics of Regulations with Allison Fulton

Insights

Articles

•Upping Hospitals' Liability Defenses For COVID Measures
Law360, 04.13.2020
•Marketing pet foods with CBD: A regulatory perspective
PetfoodIndustry.com, 12.02.2019
•FDA In Review - Highlights for Food and Other FDA-Regulated Companies
Association of National Advertisers, 11.2019
•Adapting To FDA's Proposal For Diagnosis Support Software
Law360, 11.04.2019
•FDA warning letters shed light on enforcement priorities for CBD-infused food
Food Dive, 10.17.2019
•Tips for When to Consider Legal Review of Quality System Investigations
MD+DI, 09.05.2019
•How FDA considerations impact food and beverage acquisitions
Food Dive, 08.15.2019
•Into the Weeds
Cosmetics & Toiletries, 07.2019
•What We Learned From FDA's Public Hearing On Cannabis
Law360, 06.04.2019
• 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

• Update: Key FDA Actions for COVID-19 Devices and Therapies, April 8, 2020

• Personal Protective Equipment & Ventilators: How FDA Is Increasing Supply for the US Healthcare System, March 30, 2020

• FDA Grants COVID-19 Diagnostic Emergency Use Authorizations, And Other Recent FDA Actions to Address COVID-19, March 16, 2020
• FDA Postpones Ex-US Facility Inspections, March 11, 2020
• How FDA is Reacting to the Coronavirus, and 2020 Regulatory Priorities, March 5, 2020
• FDA Year in Review: A Shifting Regulatory Landscape, January 7, 2020

• FDA Issues Warning Letters to 15 Companies, Consumer Update on CBD Safety, December 10, 2019
• Adapting To FDA’s Proposal For Diagnosis Support Software, November 8, 2019
• 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

• Key Health Care Provisions of the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), March 30, 2020
• FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests, April 22, 2019

Media Mentions

•CBD Rules In Limbo As FDA Grapples With New Cannabis Era
Law360, 10.28.2019
•Sheppard Mullin Nabs FDA Pro From Sidley Austin
Law360, 01.23.2019

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

•FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law
05.07.2020

•Life Sciences Roundtable: Critical Business Decisions During and After the COVID-19 Pandemic
Webinar, 04.28.2020

•Cannabis Webinar Wednesday: Getting Your CBD/Hemp Product To Market- Current Issues in Risk Management
02.19.2020

•Women in Healthcare Leadership Collaborative (WHLC) Presents: A View from the Capitol
2020 Healthcare Policy, Legal and Regulatory Predictions, Sheppard Mullin, New York and Sheppard Mullin, San Francisco, 01.23.2020

•Healthcare - What You Need to Know in 2020
Roundtable and Networking Event, Sheppard Mullin, Washington D.C., 12.05.2019

•Food Advertising, Labeling, and Litigation Conference: For the Food and Dietary Supplement Industries
Food and Drug Law Institute, 09.26.2019

•Hemp-CBD: Enabling Growth by Managing Legal Risks
Celesq Webinar, 09.25.2019

•Cannabis Webinar Wednesday: Hemp-CBD: Enabling Growth by Managing Legal Risks
07.17.2019