Kristin is a recognized leader in FDA regulatory practice with extensive experience working in the tobacco, animal health, pharmaceutical and medical device and food industries. She provides critical leadership—legal insights, advice and recommendations—to clients on sensitive and controversial regulatory topics affecting their products.

Kristin counsels on the approval, marketing and defense of FDA-regulated products and guides clients on their responses to actions taken by regulatory agencies. She also negotiates with regulatory agencies on behalf of clients, and assists clients in creating and implementing best practices. She advises her clients on proactive steps to avoid litigation and to implement risk mitigation recommendations.

Before joining Shook, Kristin was the deputy general counsel in charge of global regulatory legal support and litigation at a global animal health company. She also worked for more than eight years as associate chief counsel for FDA, advising the agency on sensitive, controversial and precedent-setting matters, including the approval of novel drug applications. She also developed, reviewed and evaluated various legal and regulatory documents while at FDA. She uses her insider’s knowledge of the U.S. government regulatory environment to clients’ advantage in their legal matters.

Publications

Trapped in a Regulatory Web: FDA Says Again that Hemp Extracts Containing CBD Cannot be Marketed as a Dietary Supplement, Cannabis Law Journal, October 2021 (with Katie Gates Calderon and Emily Sellers).