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Posted 22 October 2019 | By Zachary Brennan 

Submitting Manufacturing Facility Information: Final FDA Guidance

2796 The US Food and Drug Administration (FDA) on Tuesday finalized a question and answer guidance on the type of manufacturing facility information that should be included in applications submitted to the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.

FDA explains that the guidance is meant to help companies understand how not to submit extraneous information or misplaced or missing information that could result in delays, Refusal to File or Refuse to Receive actions.

For Form FDA 356h, the guidance says that applicants “should include complete information on the locations of all manufacturing, packaging, and control sites for both drug substance and drug product,” among others. However, facilities “that do not impact or inform the commercial control strategy do not need to be listed on Form FDA 356h.”

For combination products, any finished device constituent part manufacturing facilities that are proposed to be involved in the disposition of commercial products should be listed on Form FDA 356h. And if an applicant is adding a new facility or removing a previously submitted facility, this information should be captured on Form FDA 356h submitted with the amendment or supplement

An FDA Establishment Identifier (FEI) number is also necessary for FDA to proceed with the facility evaluation portion of the application assessment, the guidance says. But FDA also says applicants should not delay submissions due to the absence of an FEI number. The guidance also includes instructions on how to obtain an FEI number and a Data Universal Numbering System (DUNS) number.

“Module 3 should contain all facilities listed on Form FDA 356h, as well as research and development manufacturing and testing sites that generated data in support of the application. This includes facilities that manufactured or tested any lots of the product,” the guidance says.

Under the section on general questions and answers, the guidance also discusses Drug Master Files (DMFs) and how the facility information contained within a DMF properly incorporated by reference should be included on both Form FDA 356h and in Module 3 of the application, as appropriate. “If a facility referenced in a DMF is to be utilized for research and development or testing, this is considered part of the commercial control strategy and should be included,” FDA adds.

Excipient testers, meanwhile, do not need to be listed in the application, unless an excipient “is considered critical to the drug product performance (e.g., liposomes),” which means the testing facilities should be listed in Module 3.

The agency also pointed to forthcoming guidance due next month on the pre-submission of facility information related to prioritized generic drug applications.

As far as user fees, the guidance also explains that for PDUFA and BsUFA applications, as of October 2017, manufacturing facilities/establishments referenced in new drug applications and biologics license applications are no longer subject to user fees.

Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers


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