Investigational New Drug Application (IND)

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Drugs for Human Use
  6. Investigational New Drug Application
  7. Investigational New Drug Application (IND)

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Section
312.20

Requirement for an IND.

Section
312.21

Phases of an investigation.

Section
312.22

General principles of the IND submission.

Section
312.23

IND content and format.

Section
312.30

Protocol amendments.

Section
312.31

Information amendments.

Section
312.32

IND safety reporting.

Section
312.33

Annual reports.

Section
312.38

Withdrawal of an IND.