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CDER DATA STANDARDS MANUAL |
FDA Data Element Number.
CDER Data Element Number. C-DRG-00909
Version Number. 001
Data Element Name. Pediatric Exclusivity Study Age Group
Description. Pediatric Exclusivity Study Age Group describes the age groups for the participants in the studies that can be submitted to support pediatric exclusivity claims.
Source.
Relationship.
FDA Specifications.
CDER Specifications. Pediatric Exclusivity Study Age Group shall consist of an alphanumeric term which has a maximum length restricted to 240 characters, and a corresponding alphanumeric code with a maximum length of 3 characters. (Reference table column_id = PED_EX_STUDY_AGE_GROUP).
FDA Approved Date.
CDER Approved Date. February 1, 2000
FDA Revised Date.
CDER Revised Date.
Data Values.
| NAME | DEFINITION | FDA CODE |
|---|---|---|
| NEONATES | NEWBORNS UP TO ONE MONTH | NEO |
| INFANTS | ONE MONTH TO TWO YEARS | INF |
| CHILDREN | TWO YEARS TO TWELVE YEARS | CHI |
| ADOLESCENTS | TWELVE YEARS TO SIXTEEN YEARS | ADO |
| OTHER | OTHER AGE GROUP STUDIED | OTH |