Over his nearly 30 years of experience as an FDA regulatory attorney, Scott Lassman has strong record of success using both the Citizen Petition process and, when necessary, litigation with FDA under the Administrative Procedure Act (APA) to achieve his clients’ business objectives. The issues that rise to this level most often involve complex exclusivity and patent certification disputes, but Scott also has experience with a wide variety of other issues, including user fees, product jurisdiction, and labeling carve-outs, to name a few.
In addition, Scott sometimes serves as a consulting or testifying expert on FDA regulatory law for other law firms in commercial litigation.