CFR section
21 CFR 312.7(b): Promotion of investigational drugs
PART 312-INVESTIGATIONAL NEW DRUG APPLICATION · Subpart A-General Provisions
Key facts
| Citation | 21 CFR 312.7(b) |
|---|---|
| Section | Promotion of investigational drugs |
| Part | PART 312-INVESTIGATIONAL NEW DRUG APPLICATION |
| Subpart | Subpart A-General Provisions |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Drugs, General, Other_Regulations |
| Regulation text (excerpt) | (b) Commercial distribution of an investigational new drug. A sponsor or investigator shall not commercially distribute or test market an investigational new drug. |
At a glance
- 1–9 Inspections citing this section
- 1–9 Warning letters citing this section
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.