IND stands for Investigational New Drug Application. To bring our new drug to our patients, I need to submit an IND to the FDA. We need to prepare for the following data. If I submit an IND as a physician, this is called a research IND. If a company submits an IND, it is called a commercial IND.
1. Animal Pharmacology and Toxicology Studies
2. Manufacturing Information
3. Clinical Protocols and Clinical Team Information
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Fumi Urano