---
kind: "section"
citation: "21 C.F.R. § 312.83"
title: "21"
number: "312.83"
heading: "Treatment protocols."
url: "https://uscodex.org/cfr/21/312.83"
---

# §312.83. Treatment protocols.


If the preliminary analysis of phase 2 test results appears promising, FDA may ask the sponsor to submit a treatment protocol to be reviewed under the procedures and criteria listed in §§ [312.305](/cfr/21/312.305.md) and [312.320](/cfr/21/312.320.md). Such a treatment protocol, if requested and granted, would normally remain in effect while the complete data necessary for a marketing application are being assembled by the sponsor and reviewed by FDA (unless grounds exist for clinical hold of ongoing protocols, as provided in [§ 312.42(b)(3)(ii)](/cfr/21/312.42.md?p=b-3-ii)).


## Notes

### Amendments

[53 FR 41523, Oct. 21, 1988, as amended at 76 FR 13880, Mar. 15, 2011]

### 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.

### Amendments

[53 FR 41523, Oct. 21, 1988, as amended at 76 FR 13880, Mar. 15, 2011]