21 CFR 312.7
Promotion of investigational drugs
21 CFR 312.7 is the regulation titled “Promotion of investigational drugs” in 21 CFR Part 312, Investigational New Drug Application. Since 2021, 6 FDA warning letters have cited it.
- Letters citing it
- 6 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 312.2, in 4 letters
- Closed out
- 33% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (5 of 6). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
The regulation
Read the text of 21 CFR 312.7 (eCFR, as of Sep 1, 2026)
(a) Promotion of an investigational new drug. A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.
(b) Commercial distribution of an investigational new drug. A sponsor or investigator shall not commercially distribute or test market an investigational new drug.
(c) Prolonging an investigation. A sponsor shall not unduly prolong an investigation after finding that the results of the investigation appear to establish sufficient data to support a marketing application.
[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 19476, May 22, 1987; 67 FR 9585, Mar. 4, 2002; 74 FR 40899, Aug. 13, 2009]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 312.7.
- 21 CFR 312.2Applicability4 letters cite both
- 21 CFR 312.20Requirement for an IND4 letters cite both
- 21 CFR 312.3Definitions and interpretations3 letters cite both
- 21 CFR 1271.3How does FDA define important terms in this part?1 letter cites both
- 21 CFR 201.100Prescription drugs for human use1 letter cites both
- 21 CFR 201.115New drugs or new animal drugs1 letter cites both
- 21 CFR 201.5Drugs; adequate directions for use1 letter cites both
- 21 CFR 211.100Written procedures; deviations1 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 312.7 that FDA posted most recently.
- BiologicsView Kimera Labs, Inc.XoGlo®, XoGlo®Pro, and Amnio2X®IssuedSep 1, 2023PostedJan 4, 2024
- DrugsView Maggie Jeffries, M.D. / Avanti Anesthesiology, LLCClinical investigations of investigational drugs for anesthesiaIssuedMar 3, 2023PostedMar 14, 2023
- DrugsView CytoDyn, Inc.leronlimabIssuedFeb 11, 2022PostedFeb 22, 2022
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Counts include every citation in a letter, as the Letters filter does. How this database is built.