Zdrowie i gospodarka · 5.04.2012
Ashish Macwan: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Ashish Macwan for 5 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. Macwan was convicted of one count of conspiracy to commit an offense against the United States for conduct relating to the development and approval, including the process for development and approval, of a drug product and to the regulation of drug products under the FD&C Act. In addition, the type of conduct underlying the conviction undermined the process for the regulation of drugs. Mr. Macwan was given notice of the proposed debarment and an opportunity to request a hearing within the time frame prescribed by regulation. Mr. Macwan failed to request a hearing, which constitutes a waiver of his right to a hearing concerning this action.