Dr. Kevin Ruby, M.S., Ph.D., was a Senior Staff Reviewer with the United States Department of Agriculture's Center for Veterinary Biologics (USDA CVB) for 35 years, 11 years in the laboratory, and 24 years as a Reviewer. While in the laboratory, Dr. Ruby developed monoclonal antibodies and in vitro assays for potency testing of veterinary biologicals products containing leptospiral serovars as well as troubleshooting other potency assays and diagnostic products. As a Reviewer, Dr. Ruby has brought a wide variety of products to licensure or permitting which included reviewing approximately 40,000 documents. Dr. Ruby was also responsible for drafting and publication of the Single Tier and Labeling Final Rules that are now part of Title 9 of the Code of Federal Regulations. Since retirement in 2021, Dr. Ruby has been a consultant to veterinary biologicals industry (domestic and foreign) assisting manufacturers with licensing or permitting issues ranging from initial submissions, drafting Outlines of Production, Supplemental Information Formats, study designs, protocol/final reports, labeling, jurisdictional and USDA CVB issues.