Amy L. Johnson

Drug and Device Regulatory

Amy provides clients with drug and device regulatory and transactional advice, and counsels clients on all aspects of clinical trials. Her work includes:

• Assists clients in the life sciences industry, including major pharmaceutical and medical device companies, research institutions, and academic medical centers on a wide range of issues associated with clinical trials and research. Amy assists in the development and negotiation of clinical trial agreements, informed consent forms, policies and procedures and other important research documents. She supports companies as they develop and test their internal compliance programs, and with the negotiation of contracts with research vendors and collaboration partners. She advises on all matters related to IRBs including policies and procedures, members, compliance and governance
• Offering advice to health and life sciences clients with the development, manufacture and marketing of drugs and devices regulated by the Food and Drug Administration (FDA), and advising on good clinical practice (GCP) and current Good Manufacturing Practice (cGMP)
• Advising on matters related to data integrity, adverse event reporting and internal compliance
• Offering guidance on compliance with the Fraud & Abuse Laws in the clinical research and manufacturing fields

Senior Living and Care

Amy co-leads Faegre Drinker’s senior living and care segment and is a member of the steering committee of the health and life sciences industry team. On senior living and care issues, she leverages her experience to assist clients on transactional, compliance, regulatory and licensing matters for:

• Independent living facilities
• Assisted living facilities
• CCRCs
• Skilled nursing facilities
• Adult day facilities

Past Experience

Prior to joining the firm, Amy served as associate general counsel and executive director of insurance at a North Carolina based nonprofit health system. In that role, she managed physician employment legal strategy, relationships and contracts, independent physician contracts and relationships, medical staff matters and post-acute care legal matters, provided guidance to various Boards of Directors, provided legal health care compliance advice, and managed a comprehensive liability and casualty insurance program.