1. Regulations
  2. title 21
  3. chapter I-i7
  4. part 812
  5. subpart C
  6. § 812.42

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