Before revision: Code of Federal Regulations, Title 21, Part 312, Investigational New Drug Application Code of Federal Regulations, Title 21, Part 312, Investigational New Drug Application Code of Federal Regulations, Title 21, Part 201.56 (and Part 201.57) CDER Guidance for Industry.
After revision: Code of Federal Regulations, Title 21, Part 312, Investigational New Drug Application Code of Federal Regulations, Title 21, Part 201.56 (and Part 201.57) CDER Guidance for Industry.