Ellen Flannery advises clients on matters relating to regulation of medical devices, pharmaceuticals, and biological products. Her experience includes: helping clients to develop strategic plans with respect to the appropriate premarket pathway and development plan for obtaining FDA marketing clearance or approval; advising on dispute resolution with FDA, including representing clients in Medical Devices Dispute Resolution Panel proceedings; advising companies undertaking product recalls or responding to FDA quality system inspections; advising on advertising and promotional issues; and conducting regulatory due diligence. She also has experience with product liability, health data privacy, and antikickback laws.
Scott Danzis practice focuses primarily on the regulation of medical devices, but also includes regulation of drugs, biologics, and tobacco products. Mr. Danzis regularly works with companies in developing strategies for interacting with the U.S. Food and Drug Administration (FDA), including strategies for clinical development and premarket review (including appeals and dispute resolution, when needed). He also advises on compliance with postmarket requirements, including advertising and promotion restrictions, quality system and manufacturing requirements, postmarket reporting, recalls, and enforcement actions.
Esther Scherb’s practice focuses on healthcare reimbursement, with an emphasis on the Medicare and Medicaid programs. She advises providers, medical device, pharmaceutical and biotechnology companies, private equity firms, investment bankers and industry groups on compliance issues; the development and implementation of reimbursement strategies for new and existing technologies; and on the Centers for Medicare & Medicaid Services’ and its contractors’ coverage, coding, payment, enrollment and certification requirements. She also has represented companies in administrative and federal court litigation stemming from government audits and payment disputes.