CFR section
21 CFR 312.120(c): Foreign clinical studies not conducted under an IND
PART 312-INVESTIGATIONAL NEW DRUG APPLICATION · Subpart F-Miscellaneous
Key facts
| Citation | 21 CFR 312.120(c) |
|---|---|
| Section | Foreign clinical studies not conducted under an IND |
| Part | PART 312-INVESTIGATIONAL NEW DRUG APPLICATION |
| Subpart | Subpart F-Miscellaneous |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Drugs, General |
| Regulation text (excerpt) | (c) Waivers. (1) A sponsor or applicant may ask FDA to waive any applicable requirements under paragraphs (a)(1) and (b) of this section. A waiver request may be submitted in an IND or in an information amendment to an IND, or in an application or in an amendment or supplement to an application submitted under part 314 or 601 of this chapter. A waiver request is required to contain at least one of the following: (i) An explanation why the sponsor's or applicant's compliance with the requirement… |
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