Exploring the Latest FDA Guidelines on Master Files for BLAs and INDs
FDA’s 2024 Rule on BLAs and Master Files
Updated October 20, 2026: This article summarizes FDA’s final rule published February 12, 2024, effective March 13, 2024.
The rule clarifies when biologics applications may incorporate information from master files by reference.
Key Distinctions
- BLAs: Generally cannot reference master files for drug substance, drug substance intermediate, or drug product information. Other information may be referenced.
- Certain deemed BLAs: May continue referencing that information when it was already referenced when the application became a license.
- INDs for biological products: May reference master-file information, including those manufacturing details.
- Combination products: Separate provisions address biological and non-biological constituent parts.
Plan Beyond the IND Stage
Do not assume a master-file reference acceptable during clinical development will remain acceptable in a BLA. Evaluate information access and submission responsibilities early.
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