1. Regulations
  2. title 42
  3. chapter I
  4. part 11
  5. subpart C
  6. § 11.40

View all text of Subpart C [§ 11.40 - § 11.54]

§ 11.40 - Who must submit clinical trial results information?

The responsible party for an applicable clinical trial specified in § 11.42 must submit clinical trial results information for that clinical trial.

AUTHORITY: 42 U.S.C. 282(i); 42 U.S.C. 282(j); 5 U.S.C. 301; 42 U.S.C. 286(a); 42 U.S.C. 241(a); 42 U.S.C. 216(b).

SOURCE: 81 FR 65138, Sept. 21, 2016, unless otherwise noted.

CITE AS: 42 CFR 11.40