Final Guide Drug Manufacturing Establishment ID

FDA has made available a final guidance entitled “Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers.” The document is intended to clarify agency expectations on facility information that should be included in original NDAs, ANDAs, BLAs, and chemistry, manufacturing, and controls supplements. It discusses Form FDA 356h, which serves as both a summary of administrative information, as well as a repository of complete information on the locations of all manufacturing, packaging, and control sites for both drug substance and drug product facilities associated with an application. The guidance also addresses questions related to the inclusion and withdrawal of proposed commercial facilities and development facilities, the appropriate location within an application for facility information, and the type of facility information that should be included in applications.