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U.S. Department of Health and Human Services

Drugs

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Pediatric Exclusivity Study Type

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