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US law
Federal (United States)
Regulations
Title 21 CFR — Food and Drugs
Chapter I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Part 312 — INVESTIGATIONAL NEW DRUG APPLICATION
Subpart B — Investigational New Drug Application (IND)
Federal (United States) · Regulations
Subpart B — Investigational New Drug Application (IND)
5 sections
5 sections
21 C.F.R. § 312.22
General principles of the IND submission.
21 C.F.R. § 312.23
IND content and format.
21 C.F.R. § 312.32
IND safety reporting.
21 C.F.R. § 312.33
Annual reports.
21 C.F.R. § 312.38
Withdrawal of an IND.
Subpart B — Investigational New Drug Application (IND) | Federal (United States) Regulations | Justis AI