---
kind: "section"
citation: "21 C.F.R. § 312.88"
title: "21"
number: "312.88"
heading: "Safeguards for patient safety."
url: "https://uscodex.org/cfr/21/312.88"
---

# §312.88. Safeguards for patient safety.


All of the safeguards incorporated within parts [50](/cfr/21/part50.md), [56](/cfr/21/part56.md), 312, 314, and 600 of this chapter designed to ensure the safety of clinical testing and the safety of products following marketing approval apply to drugs covered by this section. This includes the requirements for informed consent ([part 50](/cfr/21/part50.md) of this chapter) and institutional review boards ([part 56](/cfr/21/part56.md) of this chapter). These safeguards further include the review of animal studies prior to initial human testing ([§ 312.23](/cfr/21/312.23.md)), and the monitoring of adverse drug experiences through the requirements of IND safety reports ([§ 312.32](/cfr/21/312.32.md)), safety update reports during agency review of a marketing application ([§ 314.50](/cfr/21/314.50.md) of this chapter), and postmarketing adverse reaction reporting ([§ 314.80](/cfr/21/314.80.md) of this chapter).


## Notes

### Authority

Authority: 21 U.S.C. 351, 352, 353, 355, 371; 42 U.S.C. 262.

### Source

Source: 53 FR 41523, Oct. 21, 1988, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.

### Source

Source: 52 FR 8831, Mar. 19, 1987, unless otherwise noted.