Regulations.gov document
Reference 1 - Niazi, S.K. Advice to the US FDA to Allow US Pharmacopeia to Create…
Supporting & Related Material · FDA-2025-P-6763 · posted Dec 5, 2025
Key facts
| Document ID | FDA-2025-P-6763-0003 |
|---|---|
| Title | Reference 1 - Niazi, S.K. Advice to the US FDA to Allow US Pharmacopeia to Create Biological Product Specifications (BPS) to Remove Side-by-Side Analytical Comparisons of Biosimilars with Reference Products. Pharmaceutics. 2024;16(8):1013. doi:10.3390/pharmaceutics16081013. |
| Document type | Supporting & Related Material |
| Subtype | Background Material |
| Agency | FDA |
| Docket | FDA-2025-P-6763 |
| Posted | Dec 5, 2025 |
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