Glossary Term

21 CFR 312

Regulatory

Also known as: 21 CFR Part 312, IND regulations

FDA regulations governing investigational new drug (IND) applications and the conduct of drug clinical investigations.

21 CFR Part 312 covers IND submission, sponsor and investigator responsibilities, IND safety reporting (312.32), and recordkeeping. Most drug trials in the U.S. are conducted under an IND subject to Part 312.

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