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Types of Expanded Access INDs and Protocols Referencing Investigational Drugs for Submitted NDA and BLA.
| Type of Protocol | Number |
|---|---|
| Intermediate size IND | 40 |
| Intermediate size protocol | 3 |
| Single patient, emergency IND | 345 |
| Single patient, nonemergency IND | 549 |
| Treatment IND | 4 |
| Treatment protocol | 3 |
Abbreviations: BLA, biologic licensing application; IND, investigational new drug; NDA, new drug application.
