CFR section
21 CFR 312.20(c): Requirement for an IND
PART 312-INVESTIGATIONAL NEW DRUG APPLICATION · Subpart B-Investigational New Drug Application (IND)
Key facts
| Citation | 21 CFR 312.20(c) |
|---|---|
| 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 |
| Regulation text (excerpt) | (c) A sponsor shall submit a separate IND for any clinical investigation involving an exception from informed consent under § 50.24 of this chapter. Such a clinical investigation is not permitted to proceed without the prior written authorization from FDA. FDA shall provide a written determination 30 days after FDA receives the IND or earlier. |
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