Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter D - Drugs for Human Use |
Part 312 - Investigational New Drug Application |
Subpart C - Administrative Actions |
§ 312.40 - General requirements for use of an investigational new drug in a clinical investigation. |
§ 312.41 - Comment and advice on an IND. |
§ 312.42 - Clinical holds and requests for modification. |
§ 312.44 - Termination. |
§ 312.45 - Inactive status. |
§ 312.47 - Meetings. |
§ 312.48 - Dispute resolution. |