CFR section
21 CFR 312.6(b): Labeling of an investigational new drug
PART 312-INVESTIGATIONAL NEW DRUG APPLICATION · Subpart A-General Provisions
Key facts
| Citation | 21 CFR 312.6(b) |
|---|---|
| Section | Labeling of an investigational new drug |
| Part | PART 312-INVESTIGATIONAL NEW DRUG APPLICATION |
| Subpart | Subpart A-General Provisions |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Drugs |
| Regulation text (excerpt) | (b) The label or labeling of an investigational new drug shall not bear any statement that is false or misleading in any particular and shall not represent that the investigational new drug is safe or effective for the purposes for which it is being investigated. |
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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.