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…