Drugs

Pediatric Exclusivity Study Basis

FDA Data Element Number.

CDER Data Element Number. C-DRG-00910

Version Number. 001

Data Element Name. Pediatric Exclusivity Study Basis

Description. Pediatric Exclusivity Study Basis describes the basis on which studies were done to support pediatric exclusivity claims.

Source.

Relationship.

FDA Specifications.

CDER Specifications. Pediatric Exclusivity Study Basis shall consist of an alphanumeric term which has a maximum length restricted to 240 characters, and a corresponding numeric code with a maximum length of 3 characters. (Reference table column_id = PED_EX_STUDY_BASIS).

FDA Approved Date.

CDER Approved Date. February 1, 2000

FDA Revised Date.

CDER Revised Date.

Data Values. See next page.

NAME DEFINITION FDA CODE
WRITTEN AGREEMENT PRESENT, STUDIES DONE ACCORDING TO WRITTEN AGREEMENT Literal 1
WRITTEN AGREEMENT PRESENT, STUDIES NOT DONE ACCORDING TO WRITTEN AGREEMENT Literal 2
WRITTEN AGREEMENT PRESENT, UNKNOWN IF STUDIES WERE DONE ACCORDING TO WRITTEN AGREEMENT Literal 3
WRITTEN AGREEMENT NOT PRESENT, STUDIES DONE ACCORDING TO GOOD SCIENTIFIC PRACTICES Literal 4
WRITTEN AGREEMENT NOT PRESENT, STUDIES NOT DONE ACCORDING TO GOOD SCIENTIFIC PRACTICES Literal 5
WRITTEN AGREEMENT NOT PRESENT, UNKNOWN IF STUDIES WERE DONE ACCORDING TO GOOD SCIENTIFIC PRACTICES Literal 6

 

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