Suzanne O’Shea has three decades of FDA regulatory experience. Suzanne served as Regulatory Counsel at FDA headquarters for 21 years, most recently in the Office of Combination Products. She has also worked in the FDA Regulatory Group of a major law firm. She works with drugs, biological products, devices, combination products and human tissue products.
Suzanne’s wide-ranging areas of expertise include strategic analysis of regulatory pathways depending on unique client circumstances, evolving areas of regulation such as mobile medical apps, laboratory developed tests, pharmacy compounding, Section 361 status of human tissue products, and cross-labeling requirements for combination products.
Suzanne provides due diligence in mergers and acquisitions of companies that manufacture FDA-regulated products. She serves as an expert witness when FDA processes are relevant to litigation.