Larry Bauer is a Regulatory Scientist in the Center for Drug Evaluation and Research, Office of New Drugs Immediate Office (CDER, OND IO) in the Rare Diseases Program. He provides regulatory expertise internally and externally regarding FDA laws, regulations, guidances and policies and supports the overall work of the Rare Diseases Program. Prior to coming to the FDA, he worked for 17 years at the National Institutes of Health Clinical Center.