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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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.
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