James Ravitz FDA Practice Lead
Jamie Ravitz is the practice group leader for Arent Fox’s FDA practice where he focuses on serving the life sciences and food and drug industries across all stages of the product life cycle from approval to post-market. Jamie assists manufacturers and distributors with the development of FDA regulatory pathways for novel medical technologies and device combination products (device/drug and device/biologic). He further counsels on post-approval/clearance issues such as product advertising, adverse event reporting, recalls, and QSR compliance. Jamie also advises clients on matters related to Medicare reimbursement of products regulated by the FDA. In addition to his regulatory practice, Jamie also works on health care transactional matters representing private equity in provider-based M&A. He provides health care regulatory counsel for structuring and compliance, and also represents investment banks and underwriters in conducting due diligence for public securities offerings.