Melissa GilmoreOf Counsel
Ms. Gilmore has 25 years’ experience advising clients on FDA regulatory compliance and policy, life science corporate transactions and business matters. She has counseled clients in every stage of the product and company life cycle in a broad range of industries including medical device and diagnostics, drugs, retail and compounding pharmacies, dietary supplements, food and beverage (including medical/functional foods), CBD and cannabis, tobacco and vapor, cosmetics and aesthetics, health and wellness, and veterinary products. Prior to practicing law, Ms. Gilmore was a Management Consultant whose engagements spanned multiple consumer product industries.
Ms. Gilmore’s goal is to facilitate regulatory activities that are both effective and efficient by providing business-minded legal guidance and insight, strategic analysis and value enhancement. She advises clients regularly on the federal Food, Drug & Cosmetic Act as well as on FDA policy, industry guidance and enforcement priorities. Additionally, Ms. Gilmore is recognized as a leading authority on 510(k) substantial equivalence, the de novo and PMA pathways, DSHEA, the Compounding Quality Act;, the advertising and marketing of FDA-regulated products, off-label and scientific exchange policies, and the regulation of innovative products. She also monitors key evolving issues and has spoken internationally on FDA policy and compliance.
FDA Regulatory: Ms. Gilmore has extensive experience counseling regulated clients on the full spectrum of pre- and post-market FDA regulatory compliance requirements, including developing regulatory strategy, assessing compliance posture, analyzing risk, advising on registration and listing, approval and clearance, manufacturing and cGMP, claims and labeling, marketing, advertising and promotion, supply chain and distribution and FDA inspections, and crafting and executing preventive, mitigation and remediation measures. She also advises clients facing FDA administrative and enforcement actions including Form 483s, warning letters, recalls and consent decrees. Ms. Gilmore bases her counsel on best practices to achieve compliance or defend against government investigation.
Transactional: In addition to her FDA regulatory practice, Melissa counsels lenders and investors on M&A deals, divestitures, joint ventures and financing transactions involving life science companies. She provides high level pre-event insight as well as comprehensive due diligence to advise clients on risk and growth opportunities. She is also experienced in supporting presentations and the drafting and negotiation of agreements. She regularly provides post-event regulatory counsel on transition and integration measures in furtherance of compliance and value enhancement strategies.
Advocacy and Litigation: Ms. Gilmore additionally supports advocacy and government relations efforts by advising stakeholders, legislators and regulators on developing laws, regulations, public policy and enforcement guidelines. She has been called upon to educate legislators and regulators on cutting edge issues like the 503B Compounding Quality and Dietary Supplement Ats. She also supports litigation teams by adding insight on complex compliance issues.
My latest insights
FDORA implements new FDA requirements for foreign drug and medical device companies
17 January 2023 .4 minute read
FDA denies requests for revocation of EUA for COVID vaccine for use in individuals 5-11...
5 January 2023 .5 minute read