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 has led numerous internal investigations involving allegations of off-label promotion and healthcare fraud and abuse, and she regularly counsels clients on promotion and labeling 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.
• 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• Additive manufacturing and 3D printing: US FDA’s proposed draft guidance and industry perspectives, Journal of Medical Device Regulation, November 2016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• New Draft Guidance Would Clear Regulatory Hurdles for Developers, BNA’s Medical Devices Law & Industry Report, July 2014
•Sheppard Mullin Nabs FDA Pro From Sidley Austin
Law360, January 23, 2019
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