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