Guidance Documents
As part of its guidance on Good Clinical Practice (GCP), the International Conference on Harmonisation (ICH) has prepared a detailed guidance for the contents of the IB in the European Union (EU), Japan, and the United States (US).
If many clinical trials have been completed, tables that summarize findings across the various studies can be very useful to demonstrate outcomes in, e.g., different patient populations or different indications.
- 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. Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format.
- CDER Guidance for Industry. Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format.
- CDER Guidance for Industry. Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers.
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