Washington, D.C. – Global law firm Hogan Lovells Cadwalader announced today that Mark Raza, former Chief Counsel of the U.S. Food and Drug Administration (FDA), has joined the firm's Washington, D.C. office as a senior counsel in its Pharmaceuticals and Biotechnology practice.
Raza brings more than 35 years of experience at the FDA, including service as Chief Counsel and a long career in the FDA's Office of Chief Counsel. Throughout his tenure, he advised on matters involving biological products, medical devices, information disclosure, human subject protection, combination products, and other complex issues. He also successfully represented the agency in both civil and criminal litigation and led the Office of Chief Counsel's COVID-19 emergency response team.
Raza’s arrival further strengthens Hogan Lovells Cadwalader’s market-leading FDA and life sciences practice, deepening a bench that includes former senior FDA leaders from the Office of Chief Counsel, the Office of the Commissioner, the Office of Regulatory Policy, and the compliance functions of both the drug and biologics centers. Recent additions include Melissa Mendoza, former director of the FDA’s Office of Compliance and Biologics Quality in CBER, and Elizabeth Jungman, former head of the drug center’s Office of Regulatory Policy and former chief of staff to the FDA commissioner. The team was further bolstered by the return of Xin Tao from Baker McKenzie, where he chaired the U.S. Healthcare and Life Sciences Regulatory practice. Together, the team offers unparalleled insight into FDA decision-making, policy, and enforcement priorities, drawing on firsthand experience across the full spectrum of life sciences regulation.
“Mark's arrival represents a significant milestone for our practice,” said Janice Hogan, Practice Group Leader – Global Regulatory & IP. “His distinguished career, including serving as FDA Chief Counsel, gives our clients access to exceptional insight on the legal and regulatory issues shaping the life sciences industry. Mark joins an already outstanding team, and his experience further enhances our ability to help clients navigate increasingly complex challenges.”
At the firm, Raza will advise companies on a wide range of FDA regulatory matters, enforcement issues, investigations, product development strategies, and emerging trends drawing on his experience spanning the full FDA-regulated product lifecycle. His arrival reflects the firm’s commitment to providing clients with a multidisciplinary team that combines deep experience at the intersection of business, finance, and government and includes more than 500 life sciences and health care lawyers across the globe.
“We have long been recognized for our FDA and life sciences capabilities, and Mark's arrival further strengthens one of the deepest regulatory teams in the market,” said Ajay Kuntamukkala, Office Managing Partner – Washington, D.C. “Clients are looking for advisers who understand not only where the agency is today, but where it is headed. Mark's experience at the highest levels of FDA will be invaluable as companies make strategic decisions in a rapidly evolving environment.”
“Mark is a highly respected lawyer whose contributions to FDA over more than three decades have had significant industry impacts,” said David Fox, Practice Area Leader – Pharmaceuticals and Biotechnology. “In addition to his unmatched regulatory knowledge, Mark is deeply collaborative, client-focused, and committed to mentoring the next generation of lawyers. He will be a tremendous asset to both our clients and our team.”
Raza added: “Hogan Lovells Cadwalader has built one of the premier FDA and life sciences practices in the world, and I am excited to join such a talented team. The firm's combination of regulatory excellence, industry insights, a global platform, and a commitment to client service creates the perfect environment to help companies navigate complex challenges and bring innovative products to patients. I look forward to working with my new colleagues and clients.”
Raza received his J.D. from Harvard Law School and his B.A. from Boston College.