Drugs

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.

NAMEDEFINITIONFDA CODE
NEONATESNEWBORNS UP TO ONE MONTHNEO
INFANTSONE MONTH TO TWO YEARSINF
CHILDRENTWO YEARS TO TWELVE YEARSCHI
ADOLESCENTSTWELVE YEARS TO SIXTEEN YEARSADO
OTHEROTHER AGE GROUP STUDIEDOTH

 

Page Last Updated: 12/10/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.