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Reference 3 - Niazi SK. Advice to the FDA to Improve Its Proposed Guidelines to…

Supporting & Related Material · FDA-2025-P-6763 · posted Dec 5, 2025

Key facts

Document ID FDA-2025-P-6763-0005
Title Reference 3 - Niazi SK. Advice to the FDA to Improve Its Proposed Guidelines to Rationalize Clinical Trials by Restricting Placebo Control, Preventing Low-Powered Studies, and Disallowing Studies Where Bioavailability Is Not Proven. Pharmaceuticals (Basel). 2024 Oct 24;17(11):1424. doi: 10.3390/ph17111424
Document type Supporting & Related Material
Subtype Background Material
Agency FDA
Docket FDA-2025-P-6763
Posted Dec 5, 2025

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