Table Topics and Facilitators

ALLISON FULTON is a partner in the Life Sciences and FDA Team in the Washington, DC office of Sheppard, Mullin, Richter & Hampton LLP. 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 US Food and Drug Administration (FDA). Allison’s areas of focus include assisting US 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 BS degree in Industrial Engineering from Northwestern University.