Table:
studies
Field:
expanded_access_type_treatment
Type:
boolean
Nullable:
Yes
Active:
Yes
Description:
Under a treatment IND or treatment protocol, as specified in 21 CFR 312.320. Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.