CFR section
21 CFR 312.20(a): Requirement for an IND
PART 312-INVESTIGATIONAL NEW DRUG APPLICATION · Subpart B-Investigational New Drug Application (IND)
Key facts
| Citation | 21 CFR 312.20(a) |
|---|---|
| Section | Requirement for an IND |
| Part | PART 312-INVESTIGATIONAL NEW DRUG APPLICATION |
| Subpart | Subpart B-Investigational New Drug Application (IND) |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Drugs, General |
| Regulation text (excerpt) | (a) A sponsor shall submit an IND to FDA if the sponsor intends to conduct a clinical investigation with an investigational new drug that is subject to § 312.2(a). |
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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.