Reference cardRegulations and guidance
A sponsor says 'that is in 312'. Where do I read the IND rules myself?
The IND regulations are in 21 CFR Part 312, Investigational New Drug Application. The eCFR holds the current text, including Subpart D on the responsibilities of sponsors and investigators.
Next steps
- 21 CFR Part 312, Investigational New Drug Application
- Subpart D on responsibilities of sponsors and investigators
From the question: A sponsor says 'that is in 312'. Where do I read the IND rules myself?