§320.28. Correlation of bioavailability with an acute pharmacological effect or clinical evidence.
21 C.F.R. § 320.28
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.
Notes, amendments, and revision history
Amendments
[42 FR 1648, Jan. 7, 1977, as amended at 67 FR 77674, Dec. 19, 2002]
Source
Source: 42 FR 1648, Jan. 7, 1977, unless otherwise noted.
Authority
Authority: 21 U.S.C. 321, 351, 352, 355, 371.
Amendments
[42 FR 1648, Jan. 7, 1977, as amended at 67 FR 77674, Dec. 19, 2002]