FDA Specifies DUNS for Drug Facility Registration

News
Article

FDA releases guidance specifying its preferred unique facility identifier system.

FDA Specifies DUNS for Drug Facility Registration

FDA has released guidance specifying the unique facility identifier (UFI) system for the registration of domestic and foreign drug establishments.  The guidance addresses sections 701 and 702 of the Food and Drug Administration Safety and Innovation Act (FDASIA) that direct FDA to specify the UFI system for registration of domestic and foreign drug establishments.

In the document, FDA states that it is specifying the Data Universal Numbering System (DUNS) number, assigned and managed by Dun and Bradstreet, which FDA has been using since the implementation of electronic drug registration and listing. The DUNS number is available free of charge to all drug establishments, and further information is available on FDA’s website.

Source: FDA

Recent Videos
Roger Viney from ICE Pharma discusses the quality and compliance issues surrounding the use of animal-derived ingredients in the bio/pharma industry.
Tore Bergsteiner from MAIN5 discusses the most pertinent and impactful bio/pharma industry trends from 2024.
Simon Wright from Almac Pharma Services chats about shifting demand for commercial manufacturing services and how service providers are adapting to meet demand.
Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.
Miguel Forte from ISCT and Kiji Therapeutics talks about the potential impact of a changing European political landscape.
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments