For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care.
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:
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.