CDER DATA STANDARDS MANUAL |
FDA Data Element Number.
CDER Data Element Number. C-DRG-00908
Version Number. 001
Data Element Name. Pediatric Exclusivity Study Type
Description. Pediatric Exclusivity Study Type describes the types of studies that can be submitted to support pediatric exclusivity claims.
Source.
Relationship.
FDA Specifications.
CDER Specifications. Pediatric Exclusivity Study Type 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 2 characters. (Reference table column_id = PED_EX_STUDY_TYPE).
FDA Approved Date.
CDER Approved Date. February 1, 2000
FDA Revised Date.
CDER Revised Date.
Data Values.
NAME | DEFINITION | FDA CODE |
---|---|---|
CLINICAL EFFICACY | Literal | CE |
SAFETY | Literal | SA |
PHARMACOKINETIC | Literal | PK |
OTHER | Literal | OT |