Overview

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 food, dietary supplement, pharmaceutical, medical device, and cosmetic companies in matters relating to the development, manufacture, and marketing of products regulated by the U.S. FDA.

Areas of Practice

Allison’s areas of focus include assisting U.S. and international companies comply with current Good Manufacturing Practice (GMP) and the Quality System Regulation (QSR). She regularly advises companies on preparing for FDA inspections, responding to FDA Form 483s and Warning Letters, remediating data integrity issues and handling adverse events and medical device reports (MDR). Allison assists clients with recalls and other product safety issues. She has led numerous internal investigations involving allegations of product tampering, non-compliance with GMP, and off-label promotion. She regularly counsels clients on product labeling, promotion and advertising matters.

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 provides regulatory advice during acquisitions of life science companies, and other transactions involving medical products, including product licenses and quality agreements.

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.

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"Additive manufacturing and 3D printing: US FDA's proposed draft guidance and industry perspectives," Journal of Medical Device Regulation, November 2016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"New Draft Guidance Would Clear Regulatory Hurdles for Developers," BNA's Medical Devices Law & Industry Report, July 2014

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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