Regulatory Update: Identifying Relevant Manufacturing Sites in FDA Submissions

Facilities and the 356h Form - Ensuring All Relevant Manufacturing Establishments are Appropriately Identified in FDA Drug Applications

BY Lynne Ensor, Vice President, Technical, Parexel - 12.9.19 -

FDA released its Guidance for Industry (GFI) regarding Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER: Questions and Answers on October 22, 2019.  Internally at the FDA this GFI is commonly referred to as the ‘356h guidance’, as it covers the information required on the FDA 356h form when submitting original or supplemental new drug application, abbreviated new drug application, biologics license application or a related amendment. 

Specifically, the GFI details the FDA’s expectations for facility information required on the form, including manufacturing, packaging, and control sites for both drug substance and drug product facilities associated with the application and its placement on the form.  This GFI provides for:

  • FDA’s recommendation on what information should be provided in FDA 356h form versus Module 3 of the application
     
  • Clarification that the facilities listed within the FDA 356h form do not necessarily require a facility to have an FDA Establishment Identifier (FEI) number prior to application submission.  However, indication of the FEI number on the form may expedite subsequent application processing steps. 
     
  • Clarification that all facilities listed on the FDA 356h form are not necessarily subjected to a user fee.  The function of the facility dictates whether a user fee is assessed.
     
  • A sample template to be utilized for inclusion of relevant facility information in Module 3 of the application, whose utilization is highly recommended.

Conforming to the expectations in this GFI for appropriate and complete facility information will allow firms to avoid subsequent information requests, refusal-to-file, or refuse-to-receive actions associated with applications to increase application assessment efficiency. 

Please note this is a final GFI and reflects the FDA’s current thinking on the topic.  There will not be a public comment period on the guidance prior to its finalization as this is a level 2 guidance offering clarification only and is not introducing any new policy.

 

 


We are always available for a conversation.

*