People
A partner in our FDA and Life Sciences practice, Lisa has almost 20 years of experience developing regulatory, legislative and litigation solutions for companies selling FDA-regulated products (i.e., drugs, devices, biologics, cosmetics, and tobacco). She has served as an advisor to high-level public officials and C-suite executives on complex regulatory, policy, and litigation issues.
Previously, Lisa served as a Senior Policy Advisor in the FDA Commissioner’s Office and as the Deputy Chief of Staff to the Commissioner of Food and Drugs. In these roles, she provided strategic counsel on the agency’s most significant and complex issues. These included off-label marketing, mobile medical apps/digital health, opioid misuse and abuse, in vitro diagnostics and next generation sequencing, cosmetic legislation and regulation, and antimicrobial drug development and use. During her tenure at the FDA, she also worked closely with Congress, the Department of Health and Human Services, the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and the Drug Enforcement Administration (DEA).
Lisa is a frequent author and speaker on topics including: digital health, advertising and promoting drugs and devices, remedying unfair competition in the drug and device space, women’s health issues, admissibility of 510(k)s in product liability lawsuits, preemption, in vitro diagnostics, the 21st Century Cures Act, and other topics. She was honored with the FDA Commissioner’s Special Citation in 2014 and 2015, and she was the recipient of several FDA group awards between 2011 and 2015. In 2016, Lisa was recognized for her ability in Government Relations by Legal 500. In addition, in 2017 and 2019, she was recognized by Legal 500 as a Next Generation Lawyer, and praised for her “unending enthusiasm to take on client’s causes as her own.” In 2020 and 2021, she was recognized by Legal 500 both as a Next Generation Partner and as a Recommended Key Lawyer.
J.D., George Washington University Law School, honors
B.A., Wesleyan University
District of Columbia
Massachusetts
Pennsylvania
June 8, 2023
King & Spalding Earns Top-Tier Rankings in Legal 500 United States 2023 Guide
April 11, 2023
Eric Henry, Kyle Sampson, Jessica Ringel and Lisa Dwyer’s client alert is referenced in a profile on the FDA’s PCCP guidance
January 19, 2023
Lisa Dwyer explains why she has explored using the NAD process with a number of clients, including pharma companies
Focus on Digital Health/Telehealth
Focus on In Vitro Diagnostic Tests and Laboratory Developed Tests
FDA/FTC regulation of advertising and promotion
See more
June 28, 2023
FDA Finalizes Its Premarket Submissions Guidance for Medical Device Software Functions
April 6, 2023
FDA Publishes Draft AI/ML-Enabled Medical Device Guidance. Is it Everything We Hoped?
January 9, 2023
Nearly a Century in the Making: Congress Modernizes FDA’s Regulation of Cosmetics
June 8, 2023
King & Spalding Earns Top-Tier Rankings in Legal 500 United States 2023 Guide
April 11, 2023
Eric Henry, Kyle Sampson, Jessica Ringel and Lisa Dwyer’s client alert is referenced in a profile on the FDA’s PCCP guidance
January 19, 2023
Lisa Dwyer explains why she has explored using the NAD process with a number of clients, including pharma companies
Focus on Digital Health/Telehealth
Focus on In Vitro Diagnostic Tests and Laboratory Developed Tests
FDA/FTC regulation of advertising and promotion
See more
June 28, 2023
FDA Finalizes Its Premarket Submissions Guidance for Medical Device Software Functions
April 6, 2023
FDA Publishes Draft AI/ML-Enabled Medical Device Guidance. Is it Everything We Hoped?
January 9, 2023
Nearly a Century in the Making: Congress Modernizes FDA’s Regulation of Cosmetics
June 8, 2023
King & Spalding Earns Top-Tier Rankings in Legal 500 United States 2023 Guide
April 11, 2023
Eric Henry, Kyle Sampson, Jessica Ringel and Lisa Dwyer’s client alert is referenced in a profile on the FDA’s PCCP guidance
January 19, 2023
Lisa Dwyer explains why she has explored using the NAD process with a number of clients, including pharma companies
J.D., George Washington University Law School, honors
B.A., Wesleyan University
District of Columbia
Massachusetts
Pennsylvania