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IND Regulations in Title 21 of the Code of Federal Regulations

IND Regulations are found in Title 21 of the Code of Federal Regulations (CFR), Part 312 (21 CFR 312).

Additional regulations that apply to INDs are found in 21 CFR as follows:


21 CFR Part 50 - Protection of Human Subjects


21 CFR Part 54 - Financial Disclosure by Clinical Investigators


21 CFR Part 56 - Institutional Review Boards


21 CFR Part 58 - Good Laboratory Practice for Nonclinical Laboratory (Animal) Studies


21 CFR Part 201 - Drug Labelling


21 CFR Part 312 - Investigational New Drug Application


21 CFR Part 314 - ANDA and NDA Applications for FDA Approval to Market a New Drug (New Drug Approval)


21 CFR Part 316 - Orphan Drugs