21 CFR 812.42 - FDA and IRB approval.

Regulations last checked for updates: Feb 07, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

View all text of Subpart C [§ 812.40 - § 812.47]

§ 812.42 - FDA and IRB approval.

A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both approved the application or supplemental application relating to the investigation or part of an investigation.

[46 FR 8957, Jan. 27, 1981]

authority: 21 U.S.C. 331,351,352,353,355,360,360c-360f,360h-360j,360hh-360pp,360rr-360ss,360bbb-8b,371,372,374,379e,381,382; 42 U.S.C. 216,241,262

source: 45 FR 3751, Jan. 18, 1980, unless otherwise noted.

cite as: 21 CFR 812.42