21 CFR 320.28
§ 320.28 Correlation of bioavailability with an acute pharmacological effect or clinical evidence.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 320.28, § 320.28 Correlation of bioavailability with an acute pharmacological effect or clinical evidence, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86457
- Permanent ID
ys:prov:86457@1- SHA-256
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Full text
Correlation of in vivo bioavailability data with an acute pharmacological effect or clinical evidence of safety and effectiveness may be required if needed to establish the clinical significance of a special claim, e.g., in the case of an extended release preparation.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.