Table:
studies
Field:
expanded_access_type_intermediate
Type:
boolean
Nullable:
Yes
Active:
Yes
Description:
For intermediate-size participant populations, as specified in 21 CFR 312.315. Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.