Senior Regulatory Drug Expert, Hyman, Phelps, & McNamara, P.C.
Larry Bauer is a senior regulatory drug expert with Hyman, Phelps, & McNamara, P.C. and assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Prior to this position, he worked at the FDA in CDER’s Rare Diseases Program working on policy, education, and science related to rare disease drug development and 17 years at the National Institutes of Health. He has expertise in rare pediatric disease priority review vouchers and designations, expedited programs, and patient engagement including extensive experience guiding patient advocacy groups. He also has served on the National Organization for Rare Disorders (NORD) Advocacy Committee.