Title 21

PART 812 SUBPART C

Subpart C - Responsibilities of Sponsors

• 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 360bbb-8b, 371, 372, 374, 379e, 379k-1, 381, 382, 383; 42 U.S.C. 216, 241, 262, 263b-263n.
• 45 FR 3751, Jan. 18, 1980, unless otherwise noted.

21:8.0.1.1.9.3.1.1	SECTION 812.40	812.40 General responsibilities of sponsors.
21:8.0.1.1.9.3.1.2	SECTION 812.42	812.42 FDA and IRB approval.
21:8.0.1.1.9.3.1.3	SECTION 812.43	812.43 Selecting investigators and monitors.
21:8.0.1.1.9.3.1.4	SECTION 812.45	812.45 Informing investigators.
21:8.0.1.1.9.3.1.5	SECTION 812.46	812.46 Monitoring investigations.
21:8.0.1.1.9.3.1.6	SECTION 812.47	812.47 Emergency research under § 50.24 of this chapter.

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