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U.S. Department of Health and Human Services

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Pediatric Exclusivity Study Age Group

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