|
Julie Tibbets
Partner, Chair, Life Sciences Regulatory & Compliance Practice
Goodwin
Washington, DC
USA
|
Julie Tibbets chairs Goodwin's Life Sciences Regulatory and Compliance practice at the firm. Julie focuses her practice on FDA-regulated product development, crisis resolution, product marketing and corporate communications 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, in vitro diagnostics, as well as digital therapeutics, tools and apps. Julie advises clients on product development strategy, interactions with the FDA, clinical trial conduct and documentation, adverse event reporting, commercial strategy, product labeling and advertising, and FDA inspections. 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.