James Banister is an associate in the Health Care and Business Groups.
He assists privately held and publicly traded companies across a variety of industries with corporate and business matters, such as mergers and acquisitions, joint ventures and securities. James has successfully represented healthcare providers, manufacturers and other clients in a range of transactions including hospital acquisitions and dispositions and health system joint ventures.
Additionally, James offers clients detailed and practical guidance on how to avoid and resolve FDA regulatory challenges. He imparts to clients his knowledge of the law and a keen forward-looking sense of how the agency will view a matter, so that the client can develop the most effective and persuasive approach in any given situation. James has experience representing clients on issues relating to the development and marketing of medical devices and diagnostics. His work includes: (1) helping clients comply with facility and product registration requirement, safety reports, user fees, and safe manufacturing requirements; (2) developing and reviewing advertising and marketing campaign for medical devices; (3) advising on product recalls; and (4) advising on threatened FDA enforcement actions.
James attended law school at Indiana University Robert H. McKinney School of Law, receiving his juris doctorate and graduating magna cum laude. There, James served as the Executive Articles Editor of the Indiana Health Law Review. He also worked in the law school's Appellate Clinic representing indigent defendants at the Indiana Court of Appeals and the Indiana Supreme Court.
Prior to joining Ice Miller, James worked as a microbiologist with Eli Lilly and Company in Indianapolis. He worked in parenteral manufacturing and developed extensive knowledge of current Good Manufacturing Practices (GMP) as well as other international quality standards. James has participated in Food and Drug Administration (FDA) and European Medicines Agency (EMA) compliance audits as well as Pre-Approval Inspections (PAI).
James is admitted to practice in the state of Indiana.
New Technology and Increased Globalization: Addressing Difficulties Presented in the Current FDA Inspection Process 11 Ind. Health L. Rev. 751 (2014)