With a focus on FDA law, Helen Ryan provides practically actionable advice to clients on regulatory matters before the U.S. Food and Drug Administration and related federal, state, and local agencies. She has extensive experience advising clients in the drug, biologic, and medical device industries.
Before joining Kleinfeld, Kaplan & Becker LLP, Helen worked as a life sciences regulatory and compliance associate at an AM 100 firm in Washington, D.C. There, she assisted clients with navigating FDA, DEA, and related regulatory frameworks applicable to drug and medical device products. Helen also briefly served as a regulatory counsel within FDA’s Office of Regulatory Policy within the Center for Drug Evaluation and Research (CDER). During law school, Helen interned with the Department of Justice’s Office of Vaccine Litigation, where she assisted in defending the Department of Health and Human Services against claims filed under the Vaccine Injury Compensation Program.