FDA Drug Master Files List Through Q4 2025

The FDA's list of Drug Master Files, current through the fourth quarter of 2025. It was authored by Ben Graham and is hosted by Harvard Dataverse. The specific number of records, columns, and file size are not provided.

Use Cases

• Analyze the volume and types of submissions in the FDA's Drug Master Files list to track regulatory activity.
• Cross-reference entries in the FDA Drug Master Files list with other regulatory datasets using unique identifiers.
• Monitor the update frequency of the FDA Drug Master Files list based on its last recorded update date.

Strengths

• The dataset is current through Q4 2025, providing recent regulatory information.
• It is hosted on Harvard Dataverse, a recognized academic data repository.
• The data was last updated in February 2026, indicating recent maintenance.

Limitations

• The dataset lacks metadata on the number of rows, columns, and file formats, limiting preliminary assessment.
• Without sample data or column descriptions, the specific data structure and fields are unknown.
• The scope is limited to the FDA's list, which may not include detailed content from the individual master files.

Provenance

Source

U.S. Food and Drug Administration (FDA), via Harvard Dataverse.

Collection Method

Presumably an official compilation or export from the FDA's regulatory systems.

Time Range

Through the fourth quarter of 2025.

Freshness

The data is current through Q4 2025 and was last updated on the platform in February 2026.

Geography

United States.