Julie Tibbets

Julie Tibbets chairs Goodwin’s Life Sciences Regulatory & Compliance practice at the firm and co-chairs Goodwin’s Rare Disease Initiative. In addition, she co-chairs Goodwin’s firmwide Attorney Review Committee.

Julie focuses her practice on FDA-regulated product development, clinical research, product marketing and enforcement as well as the intersection of each of those with corporate strategy and securities disclosure obligations. Her product areas of focus include biologics, drugs, medical devices, digital therapeutics, clinical decision support tools and mobile medical apps. She also leads the regulatory due diligence reviews of FDA-regulated M&A or investment targets, potential collaborators, and licensees, and guides the regulatory disclosures of FDA-regulated entities in their initial public offerings and follow-on offerings. Julie also works closely with the Food & Healthy Living practice team at Goodwin on the intersection of food, supplement, and cosmetic regulation with FDA’s drug and device authorities.

• 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
• Advised HI-Bio in connection with its $1.8 billion acquisition by Biogen
• Advised Rapport Therapeutics in its $174 million IPO
• Advised Prime Medicine in its  $175 million IPO 
• Represented Valo Health on its $2.8 billion business combination with Khosla Ventures Acquisition Co., a special purpose acquisition company (SPAC) founded by affiliates of Khosla Ventures
• Represented SpringWorks Therapeutics on regulatory matters in conjunction with its $186.3 million IPO

PRO BONO

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 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.

• Co-Author, “Common FDA Bioresearch Monitoring (BIMO) Violations: Updates from FY 2023 to Now,” Goodwin Alert, July 24, 2024
• Quoted, “4 Takeaways From FDA's Clinical Trial Diversity Guidance,” Law360, July 2024
• Co-Author, “FDA Issues Overdue Draft Guidance on Clinical Trial Diversity Action Plans,” Goodwin Insight, June 27, 2024
• Author, “Form FDA 483 Response Best Practices Announced by the FDA,” Goodwin Life Sciences Perspectives Blog, June 5, 2024
• Co-Author, “Designating a Platform Technology: FDA’s Long-Awaited Draft Guidance,” Goodwin Alert, May 29, 2024
• Contributor, “Guide to Biosimilars Litigation and Regulation in the U.S., 2023-2024 ed.,” published by Thomson Reuters, January 2024
• Co-Author, “Psychedelics & Drug Development — Key Considerations for Healthcare Industry and Life Sciences Companies as Congress Seeks to Tap Into Psychedelics’ Therapeutic Potential,” Goodwin Alert, May 31, 2023
• Co-Author, “Seven Tips for Healthcare & Life Sciences Companies Engaging Independent Monitors and Compliance Experts,” Goodwin Alert, May 24, 2023
• Co-Author, “FDA’s Final Q&A Guidance on Risk-Based Monitoring of Clinical Trials Provides Additional Recommendations for Sponsors,” Goodwin Life Sciences Perspectives Blog, April 27, 2023
• Quoted, “FDA Increasingly Halting Human Trials as Companies Pursue Risky, Cutting-Edge Drugs,” The Wall Street Journal, January 10, 2023
• Quoted, “Data Integrity Fallout: Sponsors Risk Reputational Damage, Negative Impacts On Other Research,” The Pink Sheet, January 5, 2023
• Co-Author, "U.S. CARES Act Supply Shortage Provisions: What Drug and Device Manufacturers Need to Know," Goodwin Alert, April 3, 2020
• Co-Author, “Public Health Crises and FDA Scrutiny,” PM360, March 7, 2020
• Co-Author, “Developing Medical Products for Public Health Emergencies,” Goodwin Insight, February 27, 2020
• Author, “Words & Functionalities Matter: FDA Regulation of Consumer Software and Apps,” PM360, April 15, 2019
• Author, “Talking About Your Pipeline,” PM360, January 17, 2019