Regulations and guidance
A sponsor says 'that is in 312'. Where do I read the IND rules myself?
City HallOct 13, 2026City HallOct 13, 20261 answer
The IND regulations are 21 CFR Part 312, Investigational New Drug Application. The eCFR holds the current text, including subpart D on responsibilities of sponsors and investigators.
Official sourcewww.ecfr.gov
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