Melissa Gilmore

Melissa Gilmore is a strategic operator with decades of experience in Washington, DC helping life sciences companies and their stakeholders navigate FDA issues with practical legal judgment.

Her work spans FDA-regulated industries and the full range of regulatory matters from day-to-day counseling and commercialization strategy to regulatory diligence, enforcement matters, and evolving areas of FDA oversight.

Melissa’s approach is grounded in a simple belief: the best FDA advice begins with understanding each client’s objectives. She evaluates regulatory requirements and the policy climate in the context of those objectives, ultimately translating complex FDA issues into practical guidance that helps clients identify opportunities, manage risk, and move forward effectively in the real world.

Her practice spans the full product lifecycle, including product development and classification, commercialization strategy, labeling and advertising, manufacturing and quality systems, inspections, enforcement matters, recalls, and interactions with FDA. She counsels companies from startups to established leaders across a broad range of industries, including prescription and OTC pharmaceuticals, medical devices and diagnostics, digital health, telehealth, compounding pharmacy (503A and 503B), dietary supplements, cosmetics, nicotine products, food and beverage, and other consumer health categories. Melissa is also experienced in FDA-adjacent considerations like FTC regulation of claims, import and export, and state laws governing regulated products.

Melissa also advises private equity sponsors, venture capital firms, investors, lenders, and strategic acquirers on regulatory issues that affect valuation, transaction structure, and post-transaction success. She brings FDA insight that helps clients assess regulatory risk, evaluate opportunities, and address post-closing integration and remediation.

Melissa is fluent in the policies and environment shaping enforcement priorities right now. She advises the boards of industry groups on emerging FDA issues, regulatory developments, policy considerations, and litigation affecting their members and markets. She is frequently called upon to provide insight into evolving regulatory frameworks and help stakeholders understand how regulatory changes affect their industries. She engages with policymakers and speaks internationally on FDA issues.

Melissa brings a perspective shaped by both legal and business experience. Before joining Vedder, she led the FDA practice at an AmLaw 100 firm. Earlier in her career, as a management consultant, she developed a disciplined approach to analyzing complex problems and understanding how organizations make decisions. She has also served as in-house counsel to companies in the medical device, telehealth, and nicotine industries, giving her firsthand insight into the practical challenges companies face when translating regulatory requirements into operational realities.

Melissa combines sophisticated FDA knowledge with practical legal judgment and commercial awareness, ultimately providing trusted, strategic, and bespoke advice.