CFR section
21 CFR 312.53(b): Selecting investigators and monitors
PART 312-INVESTIGATIONAL NEW DRUG APPLICATION · Subpart D-Responsibilities of Sponsors and Investigators
Key facts
| Citation | 21 CFR 312.53(b) |
|---|---|
| Section | Selecting investigators and monitors |
| Part | PART 312-INVESTIGATIONAL NEW DRUG APPLICATION |
| Subpart | Subpart D-Responsibilities of Sponsors and Investigators |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Drugs, General |
| Regulation text (excerpt) | (b) Control of drug. A sponsor shall ship investigational new drugs only to investigators participating in the investigation. |
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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.