Allison Fulton is a partner in the Life Sciences and FDA team and is based in the firm's Washington, D.C. office. Allison 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. FDA.
Allison’s areas of focus include assisting U.S. and international companies comply with premarket and postmarket 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 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 obtain benefits for service-connected disabilities.
In September, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act. The long-awaited draft guidance on Clinical Decisio...