Julie Tibbets

Julie Tibbets helps life sciences companies bring breakthrough products to market—and stay there. As chair of Goodwin’s Life Sciences Regulatory & Compliance practice and co-chair of the firm’s Rare Disease Initiative, she combines deep FDA experience with a pragmatic understanding of business objectives and a drive for advancing innovation.

From biologics and drugs to medical devices and software-based tools, Julie helps clients anticipate challenges, manage crises, and align regulatory strategy with corporate goals. She’s often the first call when an issue hits the FDA, the press, or the boardroom.

Julie regularly advises on product development, clinical trials, product marketing, GxP compliance and enforcement. She also leads due diligence and compliance reviews in public offerings, M&A, and private equity investments across the life sciences and medtech ecosystems.

• Advises early- to late-stage developers in the drug, device, and digital health areas on product development pathway strategies, regulatory submissions, meetings with the FDA, data disclosures, expedited program designations, patient engagement, disease awareness programs, and corporate communications
• Counsels numerous biopharmaceutical and medical device companies on issues that can arise during the conduct of a clinical trial, including site terminations, protocol deviations, informed consent updates, and the resolution of clinical holds
• Counsels the medical affairs and material review committees of biologic, drug, and medical device companies on managing regulatory risks and ensuring compliant pre-approval and promotional conduct and content across a broad portfolio of products and uses
• Advises on regulatory matters in the negotiation of clinical trial agreements, patient informed consents, expanded access programs, safety data exchange agreements, collaboration and development agreements, supply and distribution agreements, and quality agreements
• Conducts internal investigations on regulatory compliance matters, including investigations relating to good laboratory practices, good clinical practices, good manufacturing practices, and product promotion
• Counsels on the resolution of Form FDA-483 observations, warning letters, and product recalls

PRO BONO

Julie serves as pro bono regulatory counsel to numerous rare disease patient and research organizations and foundations in their mission to advance education and research for the rare disease patient and caregiver communities.

Julie represents The Fed Is Best Foundation in its national pursuit of regulatory, legislative, and policy changes to set minimum newborn nutritional requirements and to increase parent and health care provider education regarding newborn nutrition and safe feeding practices.

In 2020, Julie began representing VoteRiders, a nonpartisan, nonprofit organization founded in 2012 with a mission to ensure that all citizens are able to exercise their right to vote.

Julie is a member of the Food and Drug Law Institute and the Society of Clinical Research Associates.

Julie has been ranked in Washington, DC for Pharmaceuticals / Medical Products Regulatory by Chambers USA since 2018. In 2025, Chambers USA ranked Julie nationwide for Life Science: Regulatory/Compliance. In 2022, LMG Life Sciences recognized Julie as its Regulatory Attorney of the Year: FDA Pharmaceutical. She has appeared on the Washington, DC, Super Lawyers list of “Rising Stars” in the FDA area and has been selected by her peers for inclusion in The Best Lawyers in America every year since 2016 for FDA law.