OFW is pleased to announce that Rachael Vieder Linowes has joined the firm as a Principal in its Medical Products Practice. Rachael’s practice will leverage her experience at the Food and Drug Administration (FDA) to counsel clients on compliance, regulatory strategy, product development, enforcement actions, clinical trial oversight, and emerging regulatory policy.
Rachael comes to OFW directly from FDA, where she spent twelve years in regulatory counsel roles. Most recently, Rachael served as a Senior Regulatory Counsel in the Commissioner’s Office, providing counsel to FDA leaders across the agency on administrative actions and appeals. She previously worked in multiple FDA Centers and Offices, counseling agency leaders on issues relating to medical product development, enforcement actions, and compliance requirements. Rachael also played a key role in developing FDA guidance documents and regulatory policy and served on the FDA’s Institutional Review Board, where she evaluated issues related to the protection of human subjects in clinical research and clinical trials.
“Her experience provides clients with practical insight into FDA decision-making, regulatory risk management, and evolving compliance expectations, and we are thrilled to welcome Rachael to our team,” said Mason Weeda, Co-Managing Principal and Chair of the firm’s FDA practice. “Her deep understanding of FDA regulations, regulatory frameworks, compliance requirements, and enforcement policy, combined with her ability to navigate complex regulatory challenges and anticipate emerging issues affecting the life sciences industry, will make her an invaluable resource for our clients.”
