21 CFR § 312.83 - Treatment protocols.

---
identifier: "/us/cfr/t21/s312.83"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 312.83 - Treatment protocols."
title_number: 21
title_name: "Food and Drugs"
section_number: "312.83"
section_name: "Treatment protocols."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "312"
part_name: "INVESTIGATIONAL NEW DRUG APPLICATION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262."
regulatory_source: "52 FR 8831, Mar. 19, 1987, unless otherwise noted."
cfr_part: "312"
---


# 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 and 312.320. 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)).

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