Foley Hoag LLP announced that former U.S. Food and Drug Administration (FDA) attorney and senior policy official Nancy Stade has joined the firm’s Washington D.C. office as a partner. Working within the firm’s FDA practice group, Stade will focus on counseling manufacturers of medical technologies, including diagnostic tests, combination products, and Software as a Medical Device; radiation-emitting products; and consumer and digital health products.
“Nancy is a seasoned attorney with a proven track record for bringing FDA-regulated products to market,” said Areta Kupchyk, partner and co-chair of Foley Hoag’s FDA practice group. “She understands the regulations and policies affecting the entire product development process, from investigations, testing and manufacturing, to approvals, clearances, licensure and marketing. Her depth of experience is going to enhance our robust FDA, healthcare and life sciences practices.”
Stade spent more than a decade at the FDA, holding several positions in the Office of the Commissioner and the Center for Devices and Radiological Health. She helped shape multiple legislative and internal policy initiatives, including efforts to reform the FDA’s combination product programs and to develop a standard framework for laboratory developed tests. Stade also served as the agency’s senior counsel on the 21st Century Cures legislative initiative and on the MDUFA IV Executive Committee. She oversaw multiple initiatives to modernize the FDA’s oversight of digital health products, including mobile medical apps, clinical decision support tools, and general wellness products.
“Foley Hoag has a tremendous reputation in the healthcare field along with an innovative, talented and growing FDA practice,” said Stade. “I am happy to be a part of this amazing team as it continues to expand to meet the needs of its clients.”
In addition to her government service at the FDA, Stade has been a private attorney and consultant, and served as an expert in litigation concerning PMAs, the 510(k) program, and FDA requirements for manufacturer and servicers of electronic products. She has also advised private equity companies on investments in medical technologies, and advocated for them in matters before the FDA.
Stade was the principal at Stade Consulting and previously a partner at Sidley Austin. She earned her Bachelor of Arts from Columbia University and a Juris Doctorate from Columbia Law School.
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