Table:
studies
Field:
expanded_access_type_individual
Type:
boolean
Nullable:
Yes
Active:
Yes
Description:
For individual participants, including for emergency use, as specified in 21 CFR 312.310. Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.