Polsinelli announced that Claire Davies has joined the firm’s food and drug practice as a shareholder in the Denver office. Davies brings nearly a decade of experience from the U.S. Food and Drug Administration, where she played a pivotal role in high-profile legal and policy matters, including the FDA’s initiatives related to COVID-19.
Davies brings regulatory insight and practical experience, including advising on regulatory and compliance issues affecting biological products, drugs, medical devices and human cells, tissues and cellular and tissue-based products, or HCT/Ps.
During her time at the FDA, Davies was involved with COVID-19 emergency use authorizations and the response to bird flu. She played a critical role in negotiations over the reauthorization of the Medical Device User Fee Amendments and helped develop clinical research policies, including guidance on digital health technologies in clinical trials.
In her previous role, Davies advised FDA leadership on the approval of novel products, including cell therapies, and programs to expedite access to innovative medical devices. Her experience spans the product life cycle and extends to matters involving recalls, inspections, product labeling and promotion, adverse event reporting and post-market product changes, among other areas.
Additionally, Davies has substantial experience in requirements for federally regulated clinical research. She was the principal legal advisor on multiple rulemakings to revise FDA regulations governing informed consent and institutional review boards.
Polsinelli also welcomed Erin Burns to its Denver office as a shareholder in the firm’s nationwide health care practice. Burns brings insight and strategic counsel to hospices, home health agencies, skilled nursing facilities and other post-acute care providers.
Burns focuses her practice on helping clients navigate the ever-evolving regulatory environment, offering support on a wide range of matters including transactions, contracting, compliance, fraud and abuse analyses, government audits and enrollment. Her deep knowledge of Medicare and Medicaid audits allows her to guide clients through every stage of the process, ranging from eligibility denials to technical allegations.
In addition to her regulatory work, Burns also has substantial experience in health care transactions, particularly mergers and acquisitions. Her strategic approach ensures providers are positioned for long-term success while minimizing risk and maintaining regulatory compliance.
Burns earned her law degree from the University of Wisconsin Law School and her undergraduate degree from the University of Wisconsin-Madison.