Department of Health and Human Services July 2, 2012 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Sami Arshak Yanikian for 10 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Yanikian was convicted of two counts of introducing unapproved new drugs into interstate commerce, which relates to the development or approval, including the process for development or approval, of drug products and to the regulation of drug products under the FD&C Act. In addition, the type of conduct that served as the basis for Mr. Yanikian's convictions undermine the process for the regulation of drugs. Mr. Yanikian was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Yanikian failed to respond. Mr. Yanikian's failure to respond constitutes a waiver of his right to a hearing concerning this action.