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FDA (CDER)
GUIDANCE FINAL
Classification Categories for Certain Supplements Under BsUFA III
Published: 9/8/2025Detected: 3/25/2026

Summary preview

Clarifies FDA’s use of classification categories for certain supplements under BsUFA III, shaping how applicants determine supplement type and the corresponding regulatory review expectations.

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manufacturing
quality
clinical
safety
labeling
#BsUFA III
#supplements
#classification categories
#regulatory review
#postmarketing

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