The FDA released a final Q&A document titled “Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER: Questions and Answers” that provides answers to some of the most frequently asked and problematic questions raised by incomplete manufacturing, testing, packaging, etc.
The document provides specific guidance on what, where, and how to list such information in the 356h and in the relevant modules of the application. Also, it instructs firms how to report additions, deletions, and changes to facilities listed or to be listed, as well as timeframes and a preferred table for providing the information. Need to find an FEI number or DUNS number? Check out that section of the document.
Need to list excipient testers? No, you don’t, because the Agency believes that the applicant has sufficient control over the testing, receipt, and selection of excipients. Check out all of the good information in the guidance, which can be found here.