Data / Federal rules / 2024-02741
Biologics License Applications and Master Files
The Food and Drug Administration published this final rule in the Federal Register on February 12, 2024. It took effect on March 13, 2024.
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What the agency says
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to address the use of master files by applications licensed under the Public Health Service Act (PHS Act). This final rule codifies FDA's existing approach that former approved applications for certain biological products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) that have been deemed to be licenses for the biological products under the PHS Act may continue to incorporate by reference drug substance, drug substance intermediate, or drug product (DS/DSI/DP) information contained in a drug master file (DMF) if such information was being referenced at the time the application was deemed to be a license. This final rule also codifies FDA's general practices regarding the referencing of information in master files by applications licensed under the PHS Act, including applications for combination products licensed under the PHS Act, and by investigational new drug applications (INDs) for products that would be subject to licensure under the PHS Act.
Key facts
- Document number
- 2024-02741
- Type
- Final rule
- Action
- Final rule
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- February 12, 2024
- Takes effect
- March 13, 2024
- Dates
- This rule is effective March 13, 2024.
- Docket
- Docket No. FDA-2019-N-1363
- Regulation ID (RIN)
- 0910-AH50
- Code of Federal Regulations
- 21 CFR 601
- Topics
- Administrative practice and procedure; Biologics; Confidential business information
- Pages
- 15
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on administrative practice and procedure · Rules on biologics · Rules on confidential business information · Published in February 2024
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.