Lance Shea becomes national team leader of BakerHostetler's FDA practice. He was previously a partner in the Washington office of Fulbright & Jaworski.
Mr. Shea represents life sciences companies in complex regulatory and litigation matters. His clients include prominent names in the pharma, medical device, food and other sectors regulated by the FDA and EPA.
He recently advised a drug company on safety signals for a prescription product, a food manufacturer on prepping for an FDA inspection, a med device maker on the efficacy and safety claims of its product, and a drug company on comments regarding bioequivalence guidance.
On the litigation front, he recently represented a drug company in a nationwide docket of products liability cases, as well as a drug/device company on breach of contract litigation.
He frequently presents at FDA conferences, including the annual meeting of the Food & Drug Law Institute. He is past chair of the Food & Drug Law Institute’s Monograph committee.