FDA Drafts Guidance on Where to Submit Cross-Center Master Files

2nd December 2025

FDA Drafts Guidance on Where to Submit Cross-Center Master Files

Summary: The guidance, titled “Cross-Center Master Files: Where to Submit”, helps MF holders decide to which FDA centre — Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), or Center for Veterinary Medicine (CVM) — they should submit a master file that will support more than one regulatory submission (e.g. drugs, biologics, devices or combination products).

The draft guidance provides:

• Definitions and examples of “cross-center” MFs. 

• Decision criteria to determine the appropriate hosting centre (e.g. which constituent part is covered; whether the MF supports a combination product). 

• Recommendation that previously submitted MFs need not be resubmitted — applies only to new submissions under this guidance. 

By clarifying where to submit, the FDA aims to reduce confusion, avoid duplicate or inconsistent files, and streamline access for reviewers across centres — which should simplify regulatory submissions for products that combine drug, biologic or device elements.

Link: Cross-Center Master Files: Where to Submit (draft guidance)

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