About Katlin
Katlin McKelvie: Leading FDA Law Attorney in Washington, D.C.
Katlin McKelvie is a recognized leader in FDA law, providing strategic legal counsel and aggressive representation to clients navigating the complex regulatory landscape of the Food and Drug Administration. With a steadfast commitment to protecting client interests and ensuring compliance, Ms. McKelvie has consistently achieved favorable outcomes for businesses seeking to bring innovative products to market or defend against FDA actions. Her deep understanding of FDA regulations, coupled with a proactive approach to litigation and regulatory affairs, makes her a trusted partner for companies across a wide range of industries, including pharmaceuticals, medical devices, and consumer products.
Ms. McKelvie’s recognition by Best Attorney USA, continually since 2026, reflects her dedication, expertise, and the high esteem held by her peers within the legal community. This accolade, based on an exhaustive peer-review survey, underscores her commitment to providing exceptional legal service and represents a significant achievement within the competitive field of FDA law.
Practice Areas
- FDA Regulatory Compliance: We assist clients in understanding and complying with FDA regulations, including premarket submissions, labeling requirements, advertising guidelines, and post-market surveillance.
- FDA Litigation: Ms. McKelvie specializes in representing clients in FDA enforcement actions, including warning letters, seizures, and product recalls. Her experience spans a broad range of litigation matters, from initial defense strategies to complex settlement negotiations.
- New Product Development & Approval: We guide clients through the rigorous FDA approval process, assisting with submissions for new drugs, biologics, medical devices, and food products. Our experience includes navigating the FDA’s pre-submission meetings and ensuring timely and effective submissions.
- Advisory & Counsel: We provide ongoing legal advice on FDA matters, helping clients anticipate and address potential regulatory challenges. This includes staying abreast of changes in FDA regulations and providing guidance on how to adapt business practices accordingly.
- Post-Market Surveillance & Risk Management: We assist clients in managing the risks associated with post-market product monitoring, adverse event reporting, and recalls.
Education & Credentials
- Recognition: Recognized in Best Attorney USA since 2026
- Expertise: A leading attorney specializing in FDA Law
- Focus: Dedicated to providing proactive legal strategies and effective defense in FDA matters
City: Washington, State: District of Columbia, Country: United States
Ms. McKelvie’s commitment extends beyond simply navigating regulatory hurdles; she strives to build long-term partnerships with her clients, providing them with the strategic insights and legal support they need to succeed in a highly regulated industry. Her diligent approach and profound knowledge of FDA procedures consistently deliver favorable outcomes for her clients, reinforcing her position as a premier legal resource for companies operating within the FDA's jurisdiction. With a proven track record of success, Katlin McKelvie is the attorney of choice for businesses seeking a strategic partner to navigate the complexities of FDA regulation and protect their interests.
