21 C.F.R. § 812.42

Current through September 30, 2024

Section 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.

21 C.F.R. §812.42

46 FR 8957, Jan. 27, 1981